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Sponsored by: |
Federation Francophone de Cancerologie Digestive |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00541125 |
RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer.
PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: bevacizumab Biological: filgrastim Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | Phase II, Multicenter Study Evaluating G-CSF as Primary Prophylaxis for Neutropenia Associated With First-Line Chemotherapy Regimen FOLFIRI and Bevacizumab in Patients With Metastatic Colorectal Cancer Who Are Homozygous for UGT1A1*28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1 |
Estimated Enrollment: | 30 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 5-11. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2-3 months for up to 5 years.
Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed adenocarcinoma of the colon or rectum
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Active cardiac disease including any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Oral or parenteral coagulant in the past 10 days and during study therapy
Study ID Numbers: | CDR0000564089, FFCD-0604, EU-20757, EUDRACT-2007-001772-37 |
Study First Received: | October 5, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00541125 History of Changes |
Health Authority: | Unspecified |
recurrent colon cancer stage IV colon cancer recurrent rectal cancer |
stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Leucovorin Leukocyte Disorders Bevacizumab Rectal Diseases Granulocytopenia Vitamins Micronutrients Vitamin B Complex Digestive System Neoplasms |
Hematologic Diseases Agranulocytosis Rectal Neoplasm Trace Elements Folinic Acid Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Camptothecin Intestinal Neoplasms Recurrence Neutropenia Calcium, Dietary Digestive System Diseases Rectal Cancer |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Irinotecan Leucovorin Leukocyte Disorders Bevacizumab Rectal Diseases Neoplasms by Site Vitamins |
Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Vitamin B Complex Digestive System Neoplasms Hematologic Diseases Growth Substances Agranulocytosis Enzyme Inhibitors Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Intestinal Neoplasms Camptothecin |