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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070122 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen with bevacizumab works better in treating colorectal cancer.
PURPOSE: This randomized phase III trial is studying giving two different combination chemotherapy regimens together with bevacizumab and comparing how well they work in treating patients with locally advanced, metastatic, or recurrent colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: bevacizumab Drug: FOLFOX regimen Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Trial Of Modified FOLFOX6 Versus CAPOX, With Bevacizumab (NSC-704865) Or Placebo, As First-Line Therapy In Patients With Previously Untreated Advanced Colorectal Cancer |
| Study Start Date: | April 2004 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 or 1 vs 2) and prior adjuvant therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
NOTE: *As of 11/15/04, placebo is no longer part of treatment plan; all patients receive bevacizumab.
Patients are followed every 3 months until disease progression. After disease progression, patients are followed every 6 months for 2 years and then annually for up to 4 years after study entry.
PROJECTED ACCRUAL: A total of 2,200 patients (1,100 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced, recurrent, or metastatic colorectal adenocarcinoma
Previously resected colorectal cancer with new evidence of metastasis does not require separate histologic or cytologic confirmation unless one of the following is true:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No uncontrolled hypertension
Pulmonary
Other
No contraindication to oral medications (e.g., severe dysphagia)
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for advanced colorectal cancer
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
Contacts and Locations
Show 92 Study Locations| Investigator: | Charles D. Blanke, MD, FACP | Oregon Health and Science University |
| Investigator: | Heinz-Josef Lenz, MD | USC/Norris Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000330000, SWOG-S0303, ECOG-S0303 |
| Study First Received: | October 3, 2003 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00070122 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the colon adenocarcinoma of the rectum stage III colon cancer stage IV colon cancer |
stage III rectal cancer stage IV rectal cancer recurrent rectal cancer recurrent colon cancer |
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Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Leucovorin Bevacizumab Rectal Diseases Oxaliplatin Vitamins Micronutrients Capecitabine Digestive System Neoplasms Vitamin B Complex Rectal Neoplasm |
Trace Elements Folinic Acid Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Intestinal Neoplasms Recurrence Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
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Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Capecitabine Vitamin B Complex Digestive System Neoplasms Growth Substances Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil |