Clinical Trial Protocol Registry
A Dose-Finding Study of Tarceva (Erlotinib) in Combination Chemotherapy for Metastatic Colorectal Cancer.
- Protocol number:
- Roche S.p.A.
- Company division:
- Official Scientific Title:
- A study to determine the optimal dose of Tarceva, in combination with Irinotecan and Xeloda, as second line therapy in patients with metastatic colorectal cancer
- Brief summary:
- This study will evaluate the maximum tolerated dose, dose-limiting toxicity and the recommended dose of Tarceva, given in combination with escalating doses of Irinotecan and Xeloda, as secondline treatment of metastatic colorectal cancer. Patients will receive up to 8 x 21 day cycles of ascending dose treatment with Tarceva (50-150mg po, daily) Irinotecan (180-240mg/mÂ² on day 1) and Xeloda (1500-2000mg/mÂ² on days 2-15) until the maximum tolerated dose of Tarceva is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 22.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety/efficacy study
- Colorectal Cancer
- Intervention type:
- Intervention name:
- erlotinib [Tarceva]
- Primary outcome:
- Adverse events; laboratory parameters; dose-limiting toxicity.
- Key secondary outcomes:
- Complete remission; partial remission; stable disease; progressive disease; time to progression; overall survival.
- Inclusion criteria:
- adult patients, 18-65 years of age;
- proven diagnosis of colorectal cancer;
- stage IV metastatic colorectal cancer;
- refractory to first line therapy with fluoropyrimidine and/or oxaloplatin regimens.
- Exclusion criteria:
- past or current history of neoplasm other than curatively treated non-melanoma skin cancer or cancer in situ of the uterine cervix;
- clinically significant cardiovascular disease.
- Males or Females
- Age limits:
- Min: 18 years Max: 65 years
- Accepts healthy volunteers:
- Anticipated start date:
- April, 2004
- Trial registration date:
- Date last updated:
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