Trial information
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Status: Completed
Protocol number: ML18436
Sponsor: Roche Products Ltd.
Company division: Pharmaceutical
Official Scientific Title: An expanded-access program of Avastin in patients with metastatic cancer of the colon or rectum
Brief summary: This expanded access study will assess the efficacy and safety of intravenous (iv) Avastin in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 40.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Efficacy: Duration of survival; time to disease progression. Safety: Serious adverse events and targeted adverse events
Key secondary outcomes: 1. To assess the efficacy of Avastin as measured by time to disease progression and duration of survival. Pharmacoeconomics
Inclusion criteria:
- previously untreated metastatic colon or rectal cancer;
- scheduled to begin iv 5-fluorouracil- based chemotherapy as a first-line treatment;
- women of childbearing potential must have a negative serum pregnancy test 7 days prior to the administration of study drug;
- women of childbearing potential must use adequate contraception up to at least 6 months after last treatment completion, or the last drug dose, whichever occurs first.
Exclusion criteria:
- prior chemotherapy for metastatic colon or rectal cancer;
- planned radiotherapy for underlying disease;
- central nervous system metastases;
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
- treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Taiwan
- Chai Yi
- Kaohsiung
- Taichung
- Tainan
- Taipei
