Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, carboplatin, and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with autologous bone marrow transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy and autologous bone marrow transplant work in treating patients with refractory or recurrent ovarian cancer.

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

Details

• Lead Sponsor: Loyola University
• Treatments: Carboplatin; Cyclophosphamide; Mitoxantrone

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of refractory or relapsed ovarian epithelial cancer

• Must have failed prior regimen containing cisplatin or carboplatin

• Bidimensionally measurable or evaluable disease

• Serial CA-125 antigen titers or cytologically positive pleural effusion and/or ascites acceptable as evaluable disease

• Autologous bone marrow harvest of greater than 1.2 x 10 to the eighth nucleated cells/kg required before study entry

• No evidence of tumor at marrow harvest sites by bilateral bone marrow aspirates and biopsies, pelvic x-ray, and bone scan

• CNS involvement allowed

PATIENT CHARACTERISTICS:

Age:

• Under 65

Performance status:

• SWOG 0-2

Life expectancy:

• At least 8 weeks

Hematopoietic:

• WBC greater than 3,500/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 10.0 g/dL

Hepatic:

• Bilirubin less than 2.0 mg/dL

• SGOT and SGPT less than 2 times upper limit of normal

Renal:

• Creatinine clearance greater than 60 mL/min

• No prior hemorrhagic cystitis

Cardiovascular:

• LVEF greater than 45% by MUGA scan

Other:

• No hearing loss in voice tones

• No active infection

• No psychological contraindication to study treatment

• Not pregnant

• Negative pregnancy test

• HIV negative

• General medical condition must allow general anesthesia

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• No prior bone marrow transplantation

• More than 4 weeks since other prior biologic therapy and recovered

Chemotherapy:

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• More than 4 weeks since prior radiotherapy and recovered

Surgery:

• Not specified