Trial information
A Dose-Finding Study of Tarceva (Erlotinib) in Combination Chemotherapy for Metastatic Colorectal Cancer.
Status: Completed
Protocol number: MO17654
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
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/m² on day 1) and Xeloda (1500-2000mg/m² 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
30.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Adverse events; laboratory parameters; dose-limiting toxicity.
Key secondary outcomes: 1. 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 06/26/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
