Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00544011
• Other study ID #: CDR0000564118
• Secondary ID: CHRB-Folfiri-III
• Status: Recruiting
• Phase: Phase 2
• First received: October 13, 2007
• Last updated: June 23, 2011
• Start date: April 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• bevacizumab

Drug:
• capecitabine

• fluorouracil

• irinotecan hydrochloride

Other:
• diagnostic laboratory biomarker analysis

Locations

Country	Name	City	State
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Jean Minjoz

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response (complete and partial) rate			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Tolerance			Yes
Secondary	Resectability rate			No
Secondary	Biomarkers predictive of efficacy			No