Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Lenograstim; Paclitaxel; Sargramostim; Topotecan

Criteria

Inclusion Criteria:

• 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

• Curatively treated ureteral obstruction allowed if above creatinine measurements met

• No congestive heart failure

• No myocardial infarction within the past 6 months

• No significant arrhythmias requiring medication

• No poorly controlled systolic or diastolic hypertension (diastolic blood pressure consistently greater than 100 mm Hg)

• No significant nonneoplastic pulmonary disease

• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• HIV negative

• No other severe medical or psychiatric illness including, but not limited to the following:

• Acute infection

• Active peptic ulcer disease

• Uncontrolled diabetes mellitus

• Prior hospitalization for psychiatric illness, including severe depression or psychosis

• Concurrent alcohol or drug abuse

• No prior chemotherapy for this malignancy

• No radiotherapy to greater than 25% of bone marrow

• See Disease Characteristics