Cisplatin and Paclitaxel in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Completed · Phase 1
Conditions studied: Chemotherapeutic Agent Toxicity, Endometrial Adenocarcinoma, Fallopian Tube Carcinoma, Gastrointestinal Complication, Malignant Ovarian Mixed Epithelial Tumor, Neurotoxicity Syndrome, Ovarian Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Primary Peritoneal Carcinoma, Stage II Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Undifferentiated Ovarian Carcinoma
In brief
This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
Key facts
- Study ID
- NCT00814086
- Run by
- Gynecologic Oncology Group
- People needed
- 23
- Starts
- 2009-02-01
- Last updated by the study team
- 2014-12-31
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- Stage IIB, IIC, III, or IV disease
- Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks
- Appropriate tissue for histologic evaluation available
- The following histologic epithelial cell types are eligible:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
- Carcinosarcoma
- No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
- No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:
- Stage ≤ IB disease
- No more than superficial myometrial invasion, without vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion
- GOG performance status 0-2
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Cooper Hospital University Medical Center — Camden, New Jersey, United States
- Riverside Methodist Hospital — Columbus, Ohio, United States
- Tulsa Cancer Institute — Tulsa, Oklahoma, United States
- Women and Infants Hospital — Providence, Rhode Island, United States
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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