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Open-Label, Multicenter, Dose-Escalation Study in Subjects w/Advanced Colorectal Cancer to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tarceva in Combination w/5-Fluorouracil, Leucovorin, and Irinotecan and of Bevacizumab in Combination w/Tarceva, 5-Fluorouracil, Leucovorin, and Irinotecan


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Open-Label, Multicenter, Dose-Escalation Study in Subjects w/Advanced Colorectal Cancer to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tarceva in Combination w/5-Fluorouracil, Leucovorin, and Irinotecan and of Bevacizumab in Combination w/Tarceva, 5-Fluorouracil, Leucovorin, and Irinotecan

Inclusion Criteria


Subjects must fulfill all of the following criteria to be eligible for study entry:

- Signed informed consent

- At least 18 years of age

- Histologically confirmed metastatic colorectal adenocarcinoma of the colon or rectum

Resected or biopsied primary tumors or metastatic site will serve as the basis for
histologic confirmation.

- Measurable disease (defined as at least one dimension >2 cm [>1 cm on spiral CT
scans])

- ECOG performance status of 0 or 1

- Life expectancy >3 months

- Use of an effective means of contraception in men and in women of childbearing
potential

- Ability to comply with study and follow-up procedures

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

OSI2520g

NCT ID:

NCT00047762

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Mary Crowley Medical Research CenterDallas, Texas  75246
Indiana University Cancer PavilionIndianapolis, Indiana  46202