Clinical trial · Interventional
Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva
Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.
NCT00598156CI-TRIAL-00010099ACTcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab (Avastin) | Drug | Bevacizumab | ALIAS |
| erlotinib (Tarceva) | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
- interventionNames
- Drug: erlotinib (Tarceva)
- Drug: bevacizumab (Avastin)
- type
- EXPERIMENTAL
- label
- 2
- description
- bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression
- interventionNames
- Drug: bevacizumab (Avastin)
Primary outcomes (1)
- measure
- progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDHansen 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. PMID 23922111
- DERIVEDJohnsson 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. PMID 23788755