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

NCT ID: NCT00598156

Last Updated: 2013-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-08-31

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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression

Group Type: EXPERIMENTAL

erlotinib (Tarceva)

Intervention Type: DRUG

Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

bevacizumab (Avastin)

Intervention Type: DRUG

Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

2

bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression

Group Type: EXPERIMENTAL

bevacizumab (Avastin)

Intervention Type: DRUG

Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Interventions

erlotinib (Tarceva)

Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Intervention Type: DRUG

bevacizumab (Avastin)

Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Johnsson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital, Sweden

Locations

Vejle Hospital, Department of Oncology

Copenhagen, , Denmark

Esbjerg Hospital

Esbjerg, , Denmark

Herning Hospital

Herning, , Denmark

Hillerod Hospital, Department of Oncology

Hillerød, , Denmark

Odense Hospital, Department of Oncology

Odense, , Denmark

Roskilde Hospital, Department of Oncology

Roskilde, , Denmark

Ryhov Hospital, Department of Oncology

Jönköping, , Sweden

Kalmar Hospital, Department of Oncology

Kalmar, , Sweden

Lund University Hospital, Department of Oncology

Lund, , Sweden

University Hospital MAS

Malmo, , Sweden

Karolinska University Hospital, Department of Oncology

Stockholm, , Sweden

Sundsvall Hospital, Department of Oncology

Sundsvall, , Sweden

University Hospital of Norrland, Department of Oncology

Umeå, , Sweden

Akademiska Hospital, Department of Oncology

Uppsala, , Sweden

Vaxjo Hospital, Department of Oncology

Vaxjo, , Sweden

Countries

Denmark; Sweden

References

Hansen TF, Christensen Rd, Andersen RF, Sorensen FB, Johnsson A, Jakobsen A. MicroRNA-126 and epidermal growth factor-like domain 7-an angiogenic couple of importance in metastatic colorectal cancer. Results from the Nordic ACT trial. Br J Cancer. 2013 Sep 3;109(5):1243-51. doi: 10.1038/bjc.2013.448. Epub 2013 Aug 6.

Reference Type: DERIVED

PMID: 23922111 (View on PubMed)

Johnsson A, Hagman H, Frodin JE, Berglund A, Keldsen N, Fernebro E, Sundberg J, De Pont Christensen R, Garm Spindler KL, Bergstrom D, Jakobsen A. A randomized phase III trial on maintenance treatment with bevacizumab alone or in combination with erlotinib after chemotherapy and bevacizumab in metastatic colorectal cancer: the Nordic ACT Trial. Ann Oncol. 2013 Sep;24(9):2335-41. doi: 10.1093/annonc/mdt236. Epub 2013 Jun 19.

Reference Type: DERIVED

PMID: 23788755 (View on PubMed)

Other Identifiers

EUDRACT 2006-002295-18

Identifier Type: -

Identifier Source: secondary_id

ML19033

Identifier Type: -

Identifier Source: org_study_id