Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
Stopped early · Phase 2
Conditions studied: Malignant Ovarian Mixed Epithelial Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Undifferentiated Ovarian Carcinoma
In brief
Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
Key facts
- Study ID
- NCT00004221
- Run by
- Gynecologic Oncology Group
- People needed
- 12
- Starts
- 1999-11-01
- Last updated by the study team
- 2017-08-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven optimally debulked stage III ovarian or primary peritoneal carcinoma
- Any of the following subtypes:
- Serous adenocarcinoma
- Mucinous adenocarcinoma
- Clear cell carcinoma
- Transitional cell carcinoma
- Endometrioid adenocarcinoma
- Undifferentiated adenocarcinoma
- Mixed epithelial adenocarcinoma
- Adenocarcinoma, not otherwise specified
- No ovarian carcinoma of low malignant potential (borderline)
- Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma more life threatening or limiting
- Must have undergone appropriate primary surgical staging and debulking for ovarian carcinoma and have less than 1 cm of residual disease
- No more than 8 weeks since prior surgical debulking
- Must have Hickman catheter in place or be eligible for placement
- No CNS involvement
- Performance status - GOG 0 or 1
- 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
- SGOT or SGPT no greater than 2 times upper limit of normal
- No active hepatitis
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No renal failure
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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