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

Phase 3

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: erlotinib (Tarceva); Drug: bevacizumab (Avastin)

• Registration Number: NCT00598156
• Lead Sponsor: Lund University Hospital

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-18
• Primary Completion: 2009-10
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	erlotinib (Tarceva)	bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
1	bevacizumab (Avastin)	bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
2	bevacizumab (Avastin)	bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression

Primary Outcome Measures

Name	Time	Method
progression-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years

Trial Locations

Locations (15)

Roskilde Hospital, Department of Oncology; 🇩🇰 Roskilde, Denmark

Vejle Hospital, Department of Oncology; 🇩🇰 Copenhagen, Denmark

Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Herning Hospital; 🇩🇰 Herning, Denmark

Sundsvall Hospital, Department of Oncology; 🇸🇪 Sundsvall, Sweden

Akademiska Hospital, Department of Oncology; 🇸🇪 Uppsala, Sweden

Odense Hospital, Department of Oncology; 🇩🇰 Odense, Denmark

Hillerod Hospital, Department of Oncology; 🇩🇰 Hillerod, Denmark

Ryhov Hospital, Department of Oncology; 🇸🇪 Jonkoping, Sweden

Kalmar Hospital, Department of Oncology; 🇸🇪 Kalmar, Sweden

Karolinska University Hospital, Department of Oncology; 🇸🇪 Stockholm, Sweden

Vaxjo Hospital, Department of Oncology; 🇸🇪 Vaxjo, Sweden

Lund University Hospital, Department of Oncology; 🇸🇪 Lund, Sweden

University Hospital MAS; 🇸🇪 Malmo, Sweden

University Hospital of Norrland, Department of Oncology; 🇸🇪 Umeå, Sweden