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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00788411 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. ABT-869 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given together with ABT-869 or bevacizumab in treating patients with colorectal cancer.
PURPOSE: This randomized phase II trial is studying oxaliplatin, fluorouracil, and leucovorin given together with ABT-869 to see how well it works compared with oxaliplatin, fluorouracil, and leucovorin given together with bevacizumab as second-line therapy in treating patients with locally recurrent or metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: bevacizumab Drug: fluorouracil Drug: leucovorin calcium Drug: multitargeted receptor tyrosine kinase inhibitor ABT-869 Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-Line Treatment of Subjects With Advanced Colorectal Cancer |
Estimated Enrollment: | 90 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
Patients receive oxaliplatin IV over 120 minutes and leucovorin calcium IV over 120 minutes on day 1 and fluorouracil IV bolus followed by continuously IV over 46-48 hours on days 1 and 2 (mFOLFOX6). They also receive oral ABT-869 on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
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Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: multitargeted receptor tyrosine kinase inhibitor ABT-869
Given orally
Drug: oxaliplatin
Given IV
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Arm B: Experimental
Patients receive mFOLFOX6 as in arm A and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
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Drug: bevacizumab
Given IV
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients are stratified according to prior radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed periodically by FACT-C questionnaire. After completion of study therapy, patients are followed periodically for 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No symptomatic or untreated brain or meningeal metastases
PATIENT CHARACTERISTICS:
No clinically significant uncontrolled condition(s) including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
More than 21 days since prior and no concurrent non-cytotoxic anticancer therapy (e.g., investigational agents, immunotherapy, anticancer traditional Chinese medicine/herbal remedies, hormonal therapy, targeted agents [i.e., erlotinib hydrochloride, imatinib mesylate], or biologic therapy)
No concurrent therapeutic anticoagulation therapy
Responsible Party: | Vanderbilt-Ingram Cancer Center ( Jordan D. Berlin ) |
Study ID Numbers: | CDR0000618193, VU-VICC-GI-0831, ABBOTT-M10-300, IRB#080551, EudraCT-2007-007081-38 |
Study First Received: | November 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00788411 |
Health Authority: | Unspecified |
adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer stage III colon cancer |
stage IV colon cancer recurrent rectal cancer stage III rectal cancer stage IV rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
Rectal neoplasm Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients |