Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Collaborator: Hoffmann-La Roche
• Treatments: Bevacizumab; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

1. Adenocarcinoma of the colon or rectum.

2. Age > 18.

3. Measurable disease according to RECIST criteria.

4. Expected survival more than three months.

5. Adequate bone marrow, liver and kidney function.

6. INR < 1.5 times upper limit.

7. Adequate contraception for fertile patients.

8. Signed written informed consent.

Exclusion Criteria:

1. Earlier chemotherapy for metastatic colorectal cancer.

2. Adjuvant treatment within 6 months.

3. Surgery or significant trauma within 28 days prior to study entry.

4. Planned radiotherapy against target lesions.

5. CNS metastases.

6. Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.

7. Bleeding diathesis

8. Uncontrolled hypertension.

9. Significant cardiovascular disease.

10. Treatment with anticoagulant drugs.

11. Participation in other clinical trial.

12. Pregnant or lactating.