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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

Phase 2
18 Years
74 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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



- 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.


- 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

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

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.

Inclusion Criteria


- 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


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

- 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


- 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

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response at 6 months by RECIST

Safety Issue:


Principal Investigator

Martina Schneider

Investigator Role:

Study Chair

Investigator Affiliation:

Federation Francophone de Cancerologie Digestive



Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms