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KCC Clinical Trials
(click on the protocol number below for additional information on that trial)

03C.286 :    Prostate

Purpose:  To determine which is better treatment a prostate implant alone or with external beam radiation therapy

Title:  RTOG #0232: A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma.

04F.30 :    Brain & Central Nervous System

Purpose:  Research study to determine the safety of the chemotherapy drug, temozolomide when used with rituximab and methotrexate and the effect these drugs followed by radiation therapy and additional temozolomide will have on your tumor

Title:  RTOG #0227: A Phase I/II Study of Pre-Irradiation Chemotherapy with Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma

05F.513 :  Stage II: T3N0 or T4N0 Stage III: T1-2,N1; T3-4,N1; AnyT,N2  Colorectal

Purpose:  A Research Study to Compare the Results of Radiation Treatment Combined with Two Different Chemotherapy Drugs in Treating Rectal Cancer

Title:  NSABP #R-04: A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) With or Without Oxaliplatin in the Treatment of Patients With Operable Carcinoma of the Rectum

06C.549 :    Brain & Central Nervous System, Head & Neck, Pelvic Malignancies, Lung & other Thoracic Malignancies

Purpose:  A research study to determine the safety of an investigational drug Sunitinib when combined with radiation therapy.

Title:  A Phase IB, Open-Label, Safty Study of the Combination of Sunitinib and Radiation for the Treatment of Patients with Cancer

06U.20 :    Hematologic Malignancies

Title:  A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies from HLA Partially-Matched Related Donors

06U.328 :    Stem Cell Transplantation

Purpose:  Bone Marrow Transplant for Patients Without Completely Matched Donors Using a Dose-Reduced Treatment Regimen That is Given in 2 Steps.

Title:  A Two Step Approach To Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies from HLA Partially-Matched Donors.

07C.348 :    Melanoma

Purpose:  To compare progression-free survival in the dacarbazine plus Genasense group with that in the dacarbazine plus placebo treatment group. Additional secondary objectives are to compare the two treatment groups with respect to overall survival, the percentage of subjects with response and durable response, duration of response, and the safety of the 2 treatment groups.

Title:  A multicenter, randomized, double-blind study of dacarbazine with or without Genasense® in chemotherapy-naïve subjects with advanced melanoma and low LDH

07C.381 :    Brain & Central Nervous System

Purpose:  To determine the maximum tolerated dose (MTD) of Sorafenib™ Given with radiation therapy in the brain tumor population

Title:  Phase I study of combination of Sorafenib and radiation therapy for the treatment of patients with brain metastases and primary brain tumors

07C.446 :    Myelodysplastic Syndrome

Purpose:  •Determine the optimal dose of Lenalidomide (Revlimid) in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality by dose escalation within the MTD. •Determine if patients given higher doses will increase CR and PR rates as defined by IWG. Mechanism of neutropenia and thrombocytopenia observed with Lenalidomide during dose escalation by performing BM and Steroid mobilization of neutrophils.

Title:  A Phase I/II Dose-Finding Study of Lenalidomide in the Non-5q- LOW and INT-1 Risk MDS patients and Mechanism of Cytopenia

07C.71 :    Head & Neck

Purpose:  A research study to examine whether an investigational agent, Panitumumab, in combination with standard chemotherapy, is safe and effective in people with head and neck cancer.

Title:  A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-Line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-Over-Second-Line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy Only Arm (Amgen20050236). JOG 37

07D.218 :    Prostate

Purpose:  NA

Title:  Contrast Enhanced Tranrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure after XRT

07F.173 :    Bladder

Purpose:  To determine the safety and effectiveness of using the drugs paclitaxel and trastuzumab with radiation therapy in inoperable bladder cancer

Title:  RTOG#0524 - A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab with Daily Irradiation or Paclitaxel Alone with Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates with Muscle Invasive Bladder Cancer

07F.202 :    Prostate

Purpose:  Study in Men with High grade Prostatic Intraepithelial Neoplasia

Title:  Phase II, Randomized, Double-Blind, Multi-centered Study of Polyphenon E in Men with High grade Prostatic Intraepithelial Neoplasia

07F.248 :    Breast

Purpose:  NA

Title:  SWOG #0500: (CIRB) A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who have Elevated Circulating Tumor Cell Levels at First Follow-up Assessment (S0500) (NCI through ECOG)

07F.299R :    Prostate

Purpose:  To study how effective and safe prostate seed implants are for recurrent prostate cancer

Title:  A prospective Phase II trial of transperineal ultrasound-guided brachytherapy for locally recurrent prostate adenocarcinoma following external beam radiotherapy - RTOG 0526

08C.172 :    Colorectal

Purpose:  Part 1a To establish the safety and tolerability of escalating doses of AMG 706 plus Panitumumab when administered with either the FOLFIRI or FOLFOX-4 chemotherapy regimen. [Part 1a has been closed to enrollment due to safety concerns] Part 1b To establish the safety and tolerability of AMG 706 when administered with either the FOLFIRI or FOLFOX-4 chemotherapy regimen as measured by the incidence of dose-limiting toxicities Part 2 To asses overall objective tumor response rate (complete and partial response) in subjects treated with AMG 706 (at the dose determined in Part 1b), and either the FOLFIRI or FOLFOX-4 chemotherapy regimen.

Title:  An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects with Metastatic Colorectal Cancer (Amended Aug 16, 2007)

08C.246 :    Melanoma

Purpose:  The primary objective of this study is to evaluate: -the efficacy of Marqibo as determined by Disease Control Rate (CR,PR or durable SD) in patients with metastatic uveal melanoma The secondary objectives of this study are to evaluate: -response rate (CR+PR) -progression free survival -overall survival -safety

Title:  A Phase 2 Study of Marqibo in Patients with Metastatic Uveal Melanoma

08C.301 :    Brain & Central Nervous System

Purpose:  A study to evaluate the safety of the drug ABT-888 when used with radiation therapy to treat cancer that has spread to the brain

Title:  A Phase I Study of Evaluating the Safety, Tolerability and Pharmacokinetics of ABT-888 in Combination with Whole Brain Radiation Therapy in Subjects with Brain Metastases

08C.357 :    Myelodysplastic Syndrome

Purpose:  The main objective of this study is to identify a safe dose of romiplostim that is appropriate for treatment of thrombocytopenia in subjects with low or intermediate-1 risk MDS.

Title:  A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

08C.386 :    Colorectal

Purpose:  Primary objective: -To demonstrate improvement in overall survival (OS) with aflibercept by comparison to placebo in patients with colorectal cancer treated with FOLFIRI as second line treatment for metastatic disease. Secondary objectives: -To compare progression free survival (PFS) in the 2 treatment arms -To evaluate overall response rate (RR) in the 2 treatment arms -To evaluate the safety profile in the 2 treatment arms -To assess the pharmacokinetics of IV aflibercept -To assess immunogenicity of IV aflibercept

Title:  A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients with Metastatic Colorectal Cancer (MCRC) Treated with Irinotecan / 5-FU Combination (FOLFIRI) after failure of an oxaliplatin based regimen (VELOUR)

08C.522 :    Brain & Central Nervous System

Purpose:  To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Vorinostat and radiotherapy in patients with brain metastases

Title:  Phase I Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients with Brain Metastases

08C.532 :    Myeloma

Purpose:  To define the objective response rate associated with the administration of vorinostat in combination with bortezomib to patients with relapsed and refractory multiple myeloma after at least 2 prior treatment regimens, who meet both of the following conditions: 1.) refractory to bortezomib, defined as no response or disease progression in 60 days 2.) relapsed, refractory, intolerant, and/or ineligible to other therapies, including an IMiD according to the investigator

Title:  An International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Relapsed or Refractory Multiple Myeloma

08C.554 :    Esophageal

Purpose:  Primary objective: evaluate the efficacy ofOncoGel based on overall tumor response at the primary tumor site. Secondary objectives: further evaluate efficacy of OncoGel and determine safety in combination with chemoradiotherapy

Title:  A randomized study of the efficacy and safety of OncoGel™ treatment as an adjunctive therapy to systemic chemotherapy and concurrent external beam radiation prior to surgery in subjects with localized or loco-regional esophageal cancer

08C.562 :    Pancreas

Purpose:  To assess the disease-free survival rate for subjects with pancreatic carcinoma that have undergone surgical resection and intradermal administration of HyperAcute® Pancreatic cancer vaccine cells given with Gemcitabine and chemoradiation.

Title:  A Phase II Study of HyperAcute®-Pancreatic Cancer Vaccine in Subjects with Surgically Resected Pancreatic Cancer

08C.582 :    Colorectal

Purpose:  The primary objective is to estimate the treatment effect on progression-free survival (PFS) of AMG 655 plus FOLFIRI or AMG 479 plus FOLFIRI relative to FOLFIRI alone when administered as a second-line treatment for subjects with metastatic colorectal cancer (mCRC) whose tumors express mutant-type KRAS

Title:  A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

08D.482 :    Endometrial & Uterine Cancers

Purpose:  To compare health related quality of life and sexual function between patients who had adjuvant treatment for endometrial cancer by either external beam pelvic irradiation and high dose rate vaginal brachytherapy versus high dose rate vaginal brachytherapy alone. Secondarily, we plan to assess differences within each treatment group related to disease type, stage and grade; as well as characteristics of treatment including total dose of radiation, # of treatment fractions, dose per treatment fraction, duration of treatment, cylinder length and diameter, and depth of treatment.

Title:  Quality of Life and Sexual Function in Patients Treated With Either External Beam Pelvic Radiation and High Dose Vaginal Brachytherapy versus High Dose Vaginal Brachytherapy Alone for Primary Adjuvant Treatment of Endometrical Cancer

08F.126 :    Breast

Purpose:  To determine the disease-free survival of patients (defined as invasive disease-free survival (IFDS) with lymph node positive and high risk lymph node negative breast cancer randomized to treatment with either doxorubicin/cyclophosphamide plus placebo followed by paclitaxel (AC + Placebo > T + Placebo) or the same chemotherapy regimen plus bevacizumab.

Title:  E5103: A Double Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer

08F.173 :    Prostate

Purpose:  NA

Title:  CALGB #90203: Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High Risk, Clinically Localized Prostate Cancer Protocol Activation Date: 12/15/06 including update #1

08F.298 :    Prostate

Purpose:  EUCLIDIAN Robotic Assistance During Prostate Brachytherapy

Title:  Phase I Study: Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy (NIH/NCI CA 091763)

08F.324 :    Prostate

Purpose:  Objectives: 1) To determine whether the addition of NC-STAD to PBRT improves freedom from progression (FFP) for 5 years, over that of PBRT alone in men treated with salvage RT after radical prostatectomy 2) To determine whether NC-STAD+PLNRT+PBRT improves FFP over that of NC-STAD+PBRT and PBRT alone in men treated with salvage RT after radical prostatectomy.

Title:  CIRB: RTOG 0534: A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy

08F.354 :    Prostate

Purpose:  RTOG 0622

Title:  RTOG 0622: A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3-D-CRT or IMRT Irradiation in High Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy

08F.514 :    Esophageal

Purpose:  To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves overall survival compared to paclitaxel, cisplatin, and radiation alone in patients with esophageal cancer who are treated without surgery.

Title:  R0436 - A Phase III Trial Evaluating The Addition Of Cetuximab To Paclitaxel, Cisplatin, And Radiation For Patients With Esophageal Cancer Who Are Treated Without Surgery

08F.515 :    Head & Neck

Purpose:  To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard Cisplatin-based chemotherapy with or without Bevacizumab.

Title:  E1305 - A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer

09C.07 :    Leukemia

Purpose:  The rate of confirmed complete remission with or without hematopoietic recovery [complete remission (CR) and complete remission with incomplete hematopoietic recovery (CRi); this includes complete cytogenetic remission (CRc) and complete remission with persistent morphologic dysplasia (CRd)].

Title:  Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid (AML)

09C.105 :    Lung & other Thoracic Malignancies

Purpose:  To compare OS in patients with advanced NSCLC of non- adenocarcinoma tumor histology receiving erlotinib alone or CP-751,871 plus erlotinib.

Title:  Randomized, Open-Label, Phase 3 Trial of Erlotinib Alone or In Combination with CP-751,871 in Patients with Advanced Non-Small Cell Lung Cancer of Non-Adenocarcinoma Histology

09C.140 :    Colorectal

Purpose:  To determine the clinical efficacy and toxicity of ABT-869 in combination with mFOLFOX versus bevacizumab and mFOLFOX6 as second-line treatment in subjects with locally recurrent or metastatic colon or rectal cancer

Title:  As Open-Label, Randomized Phase 2 Study of ABT-869 in Combination with mFOLFOX6 (Oxaliplatin, Flurouracil, and Folonic Acid) versus Bevacizumab in Combination with mFOLFOX6 in the Second-line Treatment of Subjects with Advanced Colorectal Cancer.

09C.143 :    Melanoma

Purpose:  Assess if the addition of ABT-888 to temozolomide (TMZ) can prolong PFS compared to TMZ alone in subjects with metastatic melanoma (MM). Determine overall survival, 1-year survival rate, 6 month progression free survival rate, response rate, disease control rate, duration of overall response, quality of life, safety and tolerability, time to neurological/brain progression.

Title:  A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination with Temozolomide Versus Temozolomide Alone in Subjects with Metastatic Melanoma

09C.158 :    Lymphoma

Purpose:  To estimate antitumor activity of MLN8237 as measured by response rate in patients with relapsed or refractory Non-Hodgkin's Lymphoma

Title:  A Phase II Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients with Aggressive Non-Hodgkin’s Lymphoma

09C.216 :    Hepatocellular

Purpose:  To compare the Overall Survival (OS) of Brivanib vs Sorafenib in subjects with advanced HCC who have not received prior systemic treatment.

Title:  A Randomized, Double-blind, Multi-center Phase III Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma (The BRISK FL Study) CA 182033

09C.225 :    Lung & other Thoracic Malignancies

Purpose:  The primary objective is to demonstrate non-inferiority of overall survival (OS) when comparing subjects on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL to subjects treated with placebo.

Title:  A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

09C.250 :    Melanoma

Purpose:  To assess the efficacy in terms of Disease-Free Survival of the recMAGE-a3 + as15 ASCI in the overall population of patients

Title:  A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of reMAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected melanoma

09C.284 :    Lung & other Thoracic Malignancies

Purpose:  To assess if the addition of oral ABT-869 to carboplatin and paclitaxel can prolong progression-free survival (PFS) compared to carboplatin and paclitaxel alone in subjects with Non-Small Cell Lung Cancer.

Title:  A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination with ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment (incorporating Amendment 1 dated 14 May 2009)

09C.374 :    Prostate

Purpose:  To compare the clinical benefit of abiraterone acetate plus prednisone versus placebo plus prednisone in patients with chemotherapy-naïve castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic.

Title:  A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer

09D.99 :    Pancreas

Purpose:  Study effects of intravenous ascorbic acid in combination with gemcitabine in patients with metastatic pancreatic adenocarcinoma

Title:  Phase I, Open Label, Dose Escalating Study of Intravenous Ascorbic Acid in Combination with Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

09F.167 :    Colorectal

Purpose:  to determine the value of adding IMC-A 12 to irinotecan + cetuximab in improving PFS at 18 weeks following randomization. IMC-A 12 is a recombinant human monoclonal antibody that targets the IGF-IR. This study will also determine the value of adding IMC-A 12 to irinotecan + cetuximab in improving PFS over the entire study duration, the resection rate, overall response rate, and overall survival. Additionally, the toxicity of the regimens and the incidence rate of the immunogenicity of IMC A 12 will be evaluated.

Title:  A Randomized Phase II Clinical Trial Investigating Irinotecan Plus Cetuximab with or without Anti-Insulin Like Growth Factor-I Receptor Monoclonal Antibody (IMC-A12) for Treatment of Patients with Metastatic K-RAS Wild Type Carcinoma of the Colon or Rectum that has Progressed on Oxaliplatin and Bevacizumab Given as First-Line Therapy

09F.237 :    Brain & Central Nervous System

Purpose:  To determine whether the addition of bevacizumab to temozolomide and radiation improves efficacy as measured by progression-free and/or overall survival.

Title:  RTOG 0825: Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma

09F.239 :    Melanoma

Purpose:  To estimate the objective tumor response rate for dasatinib monotherapy in treatment-naïve or previously treated patients with advanced or metastatic acral, mucosal, or solar melanoma. Measurement of effect will be performed by RECIST criteria.

Title:  E2607: A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas

09F.420 :    Prostate, Prostate

Purpose:  A Study Comparing Docetaxel and Atrasentan to Docetaxel and Placebo For Patients with an Advanced Resistant Form of Prostate Cancer.

Title:  SWOG0421: Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer

09F.457 :    Prostate

Purpose:  For patients with intermediate risk prostate cancer, this trial will utilize dose escalated radiotherapy with or without short term androgen deprivation therapy

Title:  RTOG 0815: A Phase III prospective randomized trial of dose-escalated radiotherapy with or without short term androgen deprivation therapy for patients with intermediate risk prostate cancer

09F.463 :    Renal

Purpose:  To determine if patients with advanced transitional cell carcinoma treated with b evacizumab, gemcitabine and cisplatin will have increased overall survival when compared to patients treated with gemcitabine, cisplatin, and placebo.

Title:  A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplantin, and Placebo in Patients with Advanced Transitional Cell Carcinoma (CALGB 90601)

09F.469 :    Lung & other Thoracic Malignancies

Purpose:  Primary Objectives:To evaluate the progression-free survival of patients with extensive stage small cell lungcancer (SCLC-ED) treated with cisplatin and etoposide (CE), CE with hedgehog (HH)inhibitor GDC-0449, and CE with Insulin-like Growth Factor-I Receptor (IGF-1R) Monoclonal Antibody (IMC-A12).

Title:  E1508: A Randomized Phase II Study of Cisplatin and Etoposide In Combination with Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients with Extensive Stage Small Cell Lung Cancer

09f.470 :    Brain & Central Nervous System

Purpose:  1. To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in non-1p/19q deleted anaplastic glioma. 2. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma

Title:  RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1 PHASE III TRIAL ON CONCURRENT AND ADJUVANT TEMOZOLOMIDE CHEMOTHERAPY IN NON-1P/19Q DELETED ANAPLASTIC GLIOMA: THE CATNON INTERGROUP TRIAL

09G.104 :    Lung & other Thoracic Malignancies

Purpose:  Primary Objectives: To estimate progression-free survival following application of this treatment regimen. Secondary Objectives: • To estimate tumor response rates following application of this treatment regimen. • To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with NSCLC receiving Erlotinib with hypofractionated thoracic radiotherapy • To evaluate overall survival • To evaluate a relationship between response rates and EGFR receptor status

Title:  A Phase II Study of Erlotinib (Tarceva) and Hypofractionated Thoracic Radiotherapy for Patients with Advanced or Inoperable Non-Small-Cell Lung Cancer

 :    Breast

Purpose:  Primary Objective: To determine whether the addition of bevacizumab to the TC regimen (TCB) improves invasive disease-free survival (IDFS) relative to TC alone.

Title:  NSABP B-46-I: A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

 :    Thoracic Malignancies

Purpose:  A research study to find out if adding IMC-A12 and/or Cetuximab to standard chemotherapy is effective in treating advanced stage small cell lung cancer in patients who are not candidates for Bevacizumab.

Title:  Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination with Cetuximab, IMC-A12 or Both for Advanced Non-Small Cell Lung Cancer Patients Who Will Not Receive Bevacizumab-based Therapy (E4508)

 :    Leukemia, Myelodysplastic Syndrome

Purpose:  Determine if the addition of midostaurin to daunorubicin/cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival in both mutant FLT3-ITD and FLT-3 TKD AML patients.

Title:  A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) or Placebo in Newly Diagnosed Patients < 60 years of age with FLT3 Mutated Acute Myeloid Leukemia (AML) CALGB 10603

 :    Pancreas

Purpose:  The purpose of this pilot study is to determine the effects of a walking program on fatigue, physical functioning and quality of life (QOL) in post-operative patients with pancreatic cancer (PC) and periampullary cancers (bile duct, ampulla, duodenum) who have had surgery alone or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation therapy (RT).

Title:  Fatigue, Physical functioning, and Quality of Life in Patients with Pancreatic and Periampullary Cancers Following Surgery, Chemotherapy and/or Radiation Therapy

 :    Melanoma

Purpose:  The primary objective is to compare the following regimens with respect to antitumor activity in patients who are previously untreated with cytotoxic chemotherapy for metastatic malignant melanoma: • ABI-007 150 mg/m2 Days 1, 8, and 15 every 4 weeks • Dacarbazine 1000 mg/m2 every 3 weeks

Title:  An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients with Metastatic Malignant Melanoma

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