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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00598156

Acronym

ACT

Enrollment

249

Registered

2008-01-18

Start date

2007-06-30

Completion date

2012-08-31

Last updated

2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

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.

Interventions

DRUGerlotinib (Tarceva)

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

DRUGbevacizumab (Avastin)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
progression-free survival	3 years

Secondary

Measure	Time frame
overall survival	3 years

Countries

Denmark, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026