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NCT00778102
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.
Archived
Phase 2
Description
This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is \<100 individuals.
Target evidence in colorectal cancer
These drugs are NOT the drug used in this trial. This is published efficacy of OTHER drugs that hit the same molecular target, shown as context — it does not refer to this specific trial and does not confirm eligibility. Always review with your oncologist.
No documented evidence yet in our database for the target or drug of this trial. This section grows as new publications are processed.
Eligibility Criteria
Inclusion Criteria:
- adult patients, \>=18 years of age;
- unresectable liver metastasis secondary to cancer of colon or rectum;
- scheduled for standard first line chemotherapy;
- ECOG performance score of 0 or 1;
- condition feasible for major abdominal surgery after first line treatment.
Exclusion Criteria:
- diagnosis of metastatic disease \>3 months prior to study entry;
- evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of celiac lymph nodes;
- prior systemic or local treatment of metastatic disease;
- prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study entry;
- history or evidence of CNS disease unrelated to cancer.
Trial Information
NCT00778102
Archived
Phase 2
80 participants
Oct 2008
Locations19
Austria (1)
Vienna, 1090
France (7)
Bordeaux, 33075
Créteil, 94010
Le Mans, 72037
Lille, 59037
Lyon, 69373
Montpellier, 34298
Villejuif, 94804
Spain (7)
Palma de Mallorca, Balearic Islands, 07198
Girona, Girona, 17007
Donostia / San Sebastian, Guipuzcoa, 20080
Santiago de Compostela, La Coruña, 15706
Madrid, Madrid, 28007
Madrid, Madrid, 28046
Valencia, Valencia, 46026
United Kingdom (4)
London, WC1E 6DD
Manchester, M20 4QL
Metropolitan Borough of Wirral, CH63 4JY
Sutton, SM2 5PT