Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Recruitment status was Recruiting
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Purpose
RATIONALE: 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. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: bevacizumab Drug: capecitabine Drug: fluorouracil Drug: irinotecan hydrochloride Other: diagnostic laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma |
- Objective response (complete and partial) rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Tolerance [ Designated as safety issue: Yes ]
- Resectability rate [ Designated as safety issue: No ]
- Biomarkers predictive of efficacy [ Designated as safety issue: No ]
| Estimated Enrollment: | 47 |
| Study Start Date: | April 2007 |
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) rate in patients with metastatic colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy.
Secondary
- Determine progression-free and overall survival.
- Determine the tolerance to this regimen.
- Evaluate the resectability rate.
- Evaluate biological markers predictive of the efficacy of this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1, irinotecan hydrochloride IV over 90 minutes on days 1 and 3, and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
At 14 days after completing chemotherapy, patients with progressive or stable disease receive maintenance therapy comprising bevacizumab and capecitabine.
Biological specimens are collected at baseline and before the fourth course of chemotherapy.
After completion of study therapy, patients are followed every 3 months for 2 years.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
- Previously untreated metastatic disease
Measurable disease by RECIST
- Must not be located in a prior radiation field
- No cerebral or meningeal metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
- WHO performance status 0-1
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Transaminases ≤ 2 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases present)
- Creatinine ≤ 130 μmol/L OR creatinine clearance ≥ 30 mL/min
- Proteinuria < 2+ or urine protein ≤ 1 g/24 hours
- Not pregnant or nursing
- Fertile patients of must use effective contraception
Exclusion criteria:
- Uncontrolled cardiac disease
- Prior cerebral vascular accident
- Uncontrolled arterial hypertension
- Severe renal or hepatic insufficiency
- Prior arteriopathy
- Bleeding disorder or nonhealing wound
- Coagulopathy
- Other malignancy within the past 2 years except basal cell or squamous cell skin cancer or curatively treated carcinoma of the cervix
- Psychiatric disorder compromising comprehension or participation in the study
- Intestinal occlusion or subocclusion not caused by medical therapy
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- See Disease Characteristics
Exclusion criteria:
- Prior adjuvant bevacizumab or irinotecan hydrochloride
- Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants
- Surgery in the past 28 days
Contacts and Locations| France | |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Recruiting |
| Besancon, France, 25030 | |
| Contact: Christophe Borg, PhD 33-381-668-705 christophe.borg@efs.sante.fr | |
| Investigator: | Christophe Borg, PhD | Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00544011 History of Changes |
| Other Study ID Numbers: | CDR0000564118, CHRB-Folfiri-III-Avastin, INCA-RECF0432 |
| Study First Received: | October 13, 2007 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Additional relevant MeSH terms:
|
Adenocarcinoma Colorectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Fluorouracil Capecitabine Irinotecan Bevacizumab Camptothecin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on October 17, 2012
