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Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00628810
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: bevacizumab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI and bevacizumab therapy.
  • Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment.

Secondary

  • Evaluate progression-free survival and overall survival.
  • Determine the time to treatment failure.
  • Evaluate the quality of life (EuroQOL EQ5D questionnaire).
  • Explore the prognostic factors associated with the tolerability and efficacy of this treatment.

OUTLINE: This is a multicenter study. Patients are stratified according to genotype (UCT1A1*1/ UCT1A1*1 vs UCT1A1*1/ UCT1A1*28).

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. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the completion of study therapy.

After completion of study therapy, patients are followed every 2-3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: FOLFIRI fort plus bevacizumab
Bevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study.
Biological: bevacizumab
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium



Primary Outcome Measures :
  1. Objective response at 6 months by RECIST [ Time Frame: 6 months ]
  2. Tolerability evaluated by NCI CTC v. 2.0 criteria [ Time Frame: From Inclusion ]

Secondary Outcome Measures :
  1. Progression-free and overall survival [ Time Frame: From Inclusion ]
  2. Time to treatment failure [ Time Frame: From Inclusion ]
  3. Quality of life using the EuroQOL EQ5D questionnaire [ Time Frame: From Inclusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic adenocarcinoma of the colon or rectum

    • Not curable by surgery
  • Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/ UGT1A1*28
  • Measurable disease
  • No original tumor in place
  • No secondary cerebral metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 times normal
  • Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients of must use effective contraception

Exclusion criteria:

  • Progressive gastrointestinal ulcer, hemorrhagic ulcer, or perforation in the past 6 months
  • Enteropathy or chronic diarrhea
  • Proteinuria > 500 mg/24 hours
  • Active cardiac disease
  • Uncontrolled hypertension
  • Myocardial infarction in the past 12 months
  • Angina
  • NYHA grade II-IV congestive heart disease
  • Severe arrhythmia even with treatment
  • Peripheral vascular disease ≥ grade II
  • Nonhealing wound, ulcer, or severe bone fracture
  • Hemorrhagic diatheses or coagulopathy
  • Severe or uncontrolled infection
  • Severe or uncontrolled medical condition
  • Other malignant disease in the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the uterine cervix
  • Severe traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease

    • One prior regimen of chemotherapy in the neoadjuvant or adjuvant setting for the original tumor allowed
  • At least 6 months since prior chemotherapy
  • No prior irinotecan hydrochloride or bevacizumab
  • No oral or parenteral anticoagulant therapy within the past 10 days

    • Warfarin allowed provided INR < 1.5
  • No major surgery or biopsy within the past 4 weeks
  • No puncture in the past 7 days
  • No planned major surgery
  • No concurrent daily or chronic aspirin (> 325 mg/day), anti-inflammatories, or steroids
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628810


Locations
Show Show 32 study locations
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
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Study Chair: Martina Schneider Federation Francophone de Cancerologie Digestive
Publications of Results:
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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00628810    
Other Study ID Numbers: CDR0000564065
FFCD-0504
EUDRACT-2006-003157-25
EU-20755
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the colon
adenocarcinoma of the rectum
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
Fluorouracil
Irinotecan
Calcium
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium-Regulating Hormones and Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors