Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Under 65	Other	LUMC-3007 NCI-V91-0058, NCT00002474

Objectives

1. 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.
2. Determine the nonhematopoietic toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age:

• Under 65

Performance status:

• SWOG 0-2

Life expectancy:

• At least 8 weeks

Hematopoietic:

• WBC greater than 3,500/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Response rate
Response duration
Overall survival
Nonhematopoietic toxicity

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.

Stiff PJ, Bayer R, Kerger C, et al.: High-dose chemotherapy with autologous transplantation for persistent/relapsed ovarian cancer: a multivariate analysis of survival for 100 consecutively treated patients. J Clin Oncol 15 (4): 1309-17, 1997.[PUBMED Abstract]

Stiff P, Bayer R, Camarda M, et al.: A phase II trial of high-dose mitoxantrone, carboplatin, and cyclophosphamide with autologous bone marrow rescue for recurrent epithelial ovarian carcinoma: analysis of risk factors for clinical outcome. Gynecol Oncol 57 (3): 278-85, 1995.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Patrick Stiff, MD, Protocol chair		Ph: 708-327-3148

Registry Information
Official Title		Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin with Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
Trial Start Date		1991-02-01
Registered in ClinicalTrials.gov		NCT00002474
Date Submitted to PDQ		1991-02-01
Information Last Verified		2003-03-26

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