Ovarian Cancer Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00002474

Recruitment Status:

Completed

Sponsor:

Loyola University

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There is 1 Location for this study

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Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00002474

Recruitment Status:

Completed

Sponsor:


Loyola University

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