Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
Completed · Phase 1
Conditions studied: Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
In brief
Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy
Key facts
- Study ID
- NCT00002913
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 1996-12-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed epithelial ovarian carcinoma
- No borderline ovarian carcinoma
- Stage III/IV disease that has been suboptimally or optimally debulked
- The following histologies are eligible:
- Adenocarcinoma (unspecified)
- Mucinous cystadenocarcinoma
- Clear cell adenocarcinoma
- Serous cystadenocarcinoma
- Endometrioid adenocarcinoma
- Transitional cell carcinoma
- Malignant Brenner's tumor
- Undifferentiated carcinoma
- Mixed epithelial carcinoma
- Extraovarian papillary serous cystadenocarcinoma
- Measurable or evaluable disease
- Performance status - GOG 0-1
- Enabling completion of at least 2 courses of therapy
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No myocardial infarction within 6 months
- No congestive heart failure
- No unstable or uncontrolled angina
- No history of cardiac arrhythmia requiring anti-arrhythmia medication
Where it is running
- Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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