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

Launched by LOYOLA UNIVERSITY · Jan 26, 2003

Keywords

ClinConnect Summary

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 abse...

Gender

FEMALE

Eligibility 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

Trial Officials