Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving erlotinib together with docetaxel and carboplatin may
kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when
given together with docetaxel and carboplatin and to see how well they work in treating
patients with newly diagnosed stage III or stage IV ovarian epithelial, primary peritoneal
cavity, or fallopian tube cancer.
OBJECTIVES:
Primary
- 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
tube cancer.
Secondary
- 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
treatment courses.
- 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
regimen.
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
12 months.
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
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