Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, 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.
|Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer||Biological: pegfilgrastim Drug: carboplatin Drug: docetaxel Drug: erlotinib hydrochloride||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|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|
- Maximum tolerated dose of erlotinib
- Toxicity of maintenance therapy
- Proportion of patients who receive the full schedule of treatment courses
- Response rate
- Progression-free survival
- Overall survival
|Study Start Date:||June 2004|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217529
|United States, Washington|
|Pacific Gynecology Specialists|
|Seattle, Washington, United States, 98104|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|University of Washington School of Medicine|
|Seattle, Washington, United States, 98195|
|Study Chair:||Leona A. Holmberg, MD, PhD||Fred Hutchinson Cancer Research Center|
|Study Chair:||Dan Veljovich, MD||Pacific Gynecology Specialists|