Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00544011
First received: October 13, 2007
Last updated: June 23, 2011
Last verified: July 2009

October 13, 2007
June 23, 2011
April 2007
Not Provided
Objective response (complete and partial) rate [ Designated as safety issue: No ]
Objective response (complete and partial) rate
Complete list of historical versions of study NCT00544011 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression-free survival
  • Overall survival
  • Tolerance
  • Resectability rate
  • Biomarkers predictive of efficacy
Not Provided
Not Provided
 
Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Colorectal Cancer
  • Biological: bevacizumab
  • Drug: capecitabine
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Other: diagnostic laboratory biomarker analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
47
Not Provided
Not Provided

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
Both
18 Years to 80 Years
No
Not Provided
France
 
NCT00544011
CDR0000564118, CHRB-Folfiri-III-Avastin, INCA-RECF0432
Not Provided
Not Provided
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Not Provided
Investigator: Christophe Borg, PhD Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP