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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00598156 |
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Date of registration:
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09/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva
ACT |
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Scientific title:
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Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer. |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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249 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00598156 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Sweden
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Contacts
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Name:
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Anders Johnsson, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lund University Hospital Sweden |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Colorectal Cancer
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Intervention(s)
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Drug: bevacizumab (Avastin)
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Drug: erlotinib (Tarceva)
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Primary Outcome(s)
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progression-free survival
[Time Frame: 3 years]
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Secondary Outcome(s)
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overall survival
[Time Frame: 3 years]
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Secondary ID(s)
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EUDRACT 2006-002295-18
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ML19033
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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