Roche trials database

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 22.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• 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

Anticipated start date:

April, 2004

Trial registration date:

08.06.2006

Date last updated:

22.01.2010

This trial was conducted at the following locations:

ITALY

• MILANO

Link to trial result