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Phase III Study of an Optimized Chemotherapy + Avastin Strategy ± Tarceva in Metastatic Colorectal Cancer

Phase 3
18 Years
80 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Phase III Study of an Optimized Chemotherapy + Avastin Strategy ± Tarceva in Metastatic Colorectal Cancer



- Compare Progression-free survival during maintenance period ("Maintenance PFS")in
patients with unresectable metastatic colorectal cancer.


- Compare the duration of disease control and overall survival of patients treated with
these regimens.

- Compare the tolerability of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

- Compare the occurrence of secondary surgery in patients treated with these regimens.

- Compare the chemotherapy-free intervals and response rates in patients treated with
these regimens.


Bevacizumab IV over 30-90 minutes on day 1, combined with either:

- modified FOLFOX7 (IV : oxaliplatin, folinic acid, fluorouracil),

- XELOX2 (IV : oxaliplatin, oral capecitabine day 1 to 8),

- FOLFIRI (IV : irinotecan, folinic acid, fluorouracil).

Treatment repeats every 2 weeks.

RANDOMIZATION Patients with stable or responding disease then receive maintenance therapy
with bevacizumab alone or bevacizumab+erlotinib


- Arm A : bevacizumab alone : bevacizumab IV over 30-90 minutes on day 1

- Arm B : bevacizumab+erlotinib : bevacizumab IV over 30-90 minutes on day 1 and oral
erlotinib once daily on days 1-21.

In both arms, treatment with bevacizumab +/- erlotinib repeats every 3 weeks in the absence
of disease progression or unacceptable toxicity.

ACCRUAL: A total of 700 patients will be accrued for this study.

Inclusion Criteria


- Histologically proven metastatic adenocarcinoma of colon or rectum

- Documented inoperable disease (i.e., not suitable for complete carcinological
surgical resection)

- Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest
diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT

- No previous therapy for metastatic disease

- No history or evidence upon physical examination of CNS disease (e.g., non-irradiated
CNS metastasis, seizure not controlled with standard medical therapy, or history of
stroke) unless adequately treated

- No exclusive bone metastasis

- ECOG performance status 0-2

- WBC ≥ 1,500/mm^3

- Platelets ≥ 100,000/mm^3

- Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level)

- Proteinuria < 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection

- Bilirubin < 1.5 times ULN

- Alkaline phosphatase < 3 times ULN

- No peripheral sensory neuropathy

- Negative pregnancy test

- Fertile patients must use effective means of contraception (oral contraceptives,
intrauterine contraceptive device, barrier method of contraception in conjunction
with spermicidal jelly, or surgically sterilization)

- No peripheral neuropathy ≥ grade 1

- No clinically significant (i.e. active) cardiovascular disease

- No evidence of bleeding diathesis or coagulopathy

- No serious, non-healing wound, ulcer, or bone fracture

- No significant ophthalmologic abnormality

- More than 28 days since prior major surgical procedure or open biopsy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival during maintenance therapy

Outcome Time Frame:

Tumor evaluation every 2 months

Safety Issue:


Principal Investigator

Aimery de Gramont, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Saint Antoine


France : Agence Française de Sécurité Sanitaire et Produits de Santé (AFSSAPS)

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

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