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

Study Overview
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Brief Summary
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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).

Detailed Description
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Patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab) will be given during the treatment period. After the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.

Official Title
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Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: erlotinib (Tarceva)
* Drug: bevacizumab (Avastin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adenocarcinoma of the colon or rectum. Age > 18. Measurable disease according to RECIST criteria. Expected survival more than three months. Adequate bone marrow, liver and kidney function. INR < 1.5 times upper limit. Adequate contraception for fertile patients. Signed written informed consent. Exclusion Criteria: Earlier chemotherapy for metastatic colorectal cancer. Adjuvant treatment within 6 months. Surgery or significant trauma within 28 days prior to study entry. Planned radiotherapy against target lesions. CNS metastases. Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma. Bleeding diathesis Uncontrolled hypertension. Significant cardiovascular disease. Treatment with anticoagulant drugs. Participation in other clinical trial. Pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression | Drug: erlotinib (Tarceva)<br>* Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)<br>Drug: bevacizumab (Avastin)<br>* Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)<br>|
| Experimental: 2<br>bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression | Drug: bevacizumab (Avastin)<br>* Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years |