RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide, carboplatin, mitoxantrone and autologous bone marrow transplantation in treating patients with refractory or recurrent ovarian cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer	Drug: carboplatin  Drug: cyclophosphamide  Drug: mitoxantrone  Procedure: autologous bone marrow transplantation  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: bone marrow transplantation  Procedure: chemotherapy  Procedure: high-dose chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response rate, duration of response, and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide, carboplatin, and mitoxantrone followed by autologous bone marrow transplantation.
• Determine the nonhematopoietic toxicity of this regimen in these patients.

OUTLINE: Autologous bone marrow is harvested before study entry. Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity. Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.5-3 years.

Ages Eligible for Study:  up to  64 Years,  Genders Eligible for Study:  Both

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

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting

Study chairs or principal investigators

Patrick J. Stiff, MD,  Study Chair,  Loyola University   

Study ID Numbers:  CDR0000076845; LUMC-3007; NCI-V91-0058; NCT00002474
Record last reviewed:  September 2003
Last Updated:  December 3, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002474
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08