A Phase 1/2 interventional study of pegfilgrastim and carboplatin in Fallopian Tube Cancer, Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-21.
Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Treatment
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
Secondary
OUTLINE: This is a multicenter, dose-escalation study of erlotinib.
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
Browse Ovarian Neoplasms studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
The following histologic epithelial cell types are allowed:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Meets 1 of the following criteria:
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
No planned interval cytoreductive surgery
Other
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
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center