A Phase I-II Study of OSI-774 (Tarceva, Erlotinib) With Docetaxel/Carboplatin Followed by Maintenance Therapy With Tarceva as Treatment for Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
- Determine the maximum tolerated dose (MTD) of erlotinib when administered in
combination with docetaxel and carboplatin as front-line therapy in patients with newly
diagnosed stage III or IV ovarian epithelial, primary peritoneal cavity, or fallopian
- Determine the toxicity of maintenance therapy with erlotinib when administered after
front-line therapy in these patients.
- Determine the proportion of patients who are able to receive the full schedule of
- Determine the objective response rate in patients with measurable or evaluable disease
treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this
OUTLINE: This is a multicenter, dose-escalation study of erlotinib.
- Front-line therapy: Patients receive docetaxel IV over 1 hour and carboplatin IV over
30 minutes on day 1, pegfilgrastim subcutaneously on day 2, and oral erlotinib once
daily on days 3-16. Treatment repeats every 21 days for up to 6 courses.
Cohorts of 5 patients receive escalating doses of erlotinib until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients
experience dose-limiting toxicity.
- Maintenance therapy: Beginning 3-4 weeks after the completion of front-line therapy,
patients with stable or responding disease receive oral erlotinib once daily for up to
After completion of study treatment, patients are followed every 6 months for 1 year and
then periodically thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum tolerated dose of erlotinib
Leona A. Holmberg, MD, PhD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Washington School of Medicine||Seattle, Washington 98195|
|Pacific Gynecology Specialists||Seattle, Washington 98104|