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

06U.20 :    Hematologic Malignancies

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

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

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)

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.298 :    Prostate

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

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.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.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

09D.99 :    

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.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)

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

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