Combination Chemotherapy and Autologous Peripheral Stem Cell Transplant in Treating Patients With Stage III, Stage IV, or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cyclophosphamide, paclitaxel, melphalan, and cisplatin, followed by an autologous peripheral stem cell transplant in treating patients with stage III, stage IV, or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Cyclophosphamide; Melphalan; Paclitaxel; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or epithelial carcinoma of the fallopian tubes, meeting 1 of the following criteria:

• Stage III or IV disease that was treated with initial therapy comprising a standard platinum-containing regimen

• Must have < 2 cm of residual disease with no evidence of disease progression after initial chemotherapy AND have no disease progression immediately prior to stem cell collection

• Patients initially presenting with stage IV disease who have achieved a clinical response (complete response [CR] or partial response [PR]) after initial therapy are eligible

• Responding recurrent disease

• Patients who have had recurrence with elevated CA 125 levels (> 100 U/mL) and who have achieved a reduction of CA 125 level by 50% for 4 weeks following the most recent course of reinduction chemotherapy are eligible

• Patients who have achieved a CR or PR after salvage chemotherapy for relapsed disease are eligible

• Patients with measurable or evaluable disease must have achieved a PR after prior therapy

• No clinically significant pleural effusions

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• ANC > 1,000/μL

• Platelet count > 100,000/μL

• Serum bilirubin < 1.5 mg/dL

• SGOT and SGPT ≤ 2.5 times normal

• Creatinine clearance ≥ 60 mL/min

• No active cardiac disease that, in the opinion of the investigator, would preclude safe administration of chemotherapy

• Cardiac ejection fraction normal at rest by MUGA

• No history of potentially disabling psychiatric disorders

• Hepatitis B antigen, hepatitis C antibody, and HIV antibody negative

• No clinically significant peripheral neuropathy

• FEV_1 ≥ 2.0 L or ≥ 75% of the lower limit of normal

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy or radiotherapy

• No prior radiotherapy to the whole abdomen