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Trial record 64 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00544011
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 16, 2007
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 13, 2007
First Posted Date  ICMJE October 16, 2007
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE April 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2007)
Objective response (complete and partial) rate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00544011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2007)
  • Progression-free survival
  • Overall survival
  • Tolerance
  • Resectability rate
  • Biomarkers predictive of efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Official Title  ICMJE Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Biological: bevacizumab
  • Drug: capecitabine
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Other: diagnostic laboratory biomarker analysis
Study Arms  ICMJE Not Provided
Publications * Jary M, Lecomte T, Bouché O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Léger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 13, 2007)
47
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00544011
Other Study ID Numbers  ICMJE CDR0000564118
CHRB-Folfiri-III-Avastin
INCA-RECF0432
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hopital Jean Minjoz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Christophe Borg, PhD Hopital Jean Minjoz
PRS Account National Cancer Institute (NCI)
Verification Date July 2009

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