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A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

NCT00577109

WithdrawnPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Colorectal Cancer

Interventions: bevacizumab [Avastin], Irinotecan, Leucovorin, 5 FU, Cetuximab

Countries: Brazil

This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* adult patients, \>=18 years of age;
* colorectal cancer;
* advanced or recurrent disease;
* \>=1 measurable lesion;
* \>=6 months since prior adjuvant therapy, and \>=4 weeks since prior radiotherapy.

Exclusion Criteria:

* previous treatment for colorectal cancer;
* significant history of cardiac disease in past 6 months;
* other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.

Locations (3)

Salvador, Brazil
São Paulo, Brazil
Sorocaba, Brazil