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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
cyclophosphamide
mitoxantrone hydrochloride
autologous bone marrow transplantation
bone marrow ablation with stem cell support
Sponsored by
Loyola University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer

Eligibility Criteria

undefined - 64 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

Outcomes

Primary Outcome Measures

Response rate
Response duration
Overall survival
Nonhematopoietic toxicity

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 29, 2013
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT00002474
Brief Title
Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer
Official Title
Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
February 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Loyola University

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Primary Outcome Measure Information:
Title
Response rate
Title
Response duration
Title
Overall survival
Title
Nonhematopoietic toxicity

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. Stiff, MD
Organizational Affiliation
Loyola University
Official's Role
Study Chair
Facility Information:
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153-5500
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9193322
Citation
Stiff PJ, Bayer R, Kerger C, Potkul RK, Malhotra D, Peace DJ, Smith D, Fisher SG. High-dose chemotherapy with autologous transplantation for persistent/relapsed ovarian cancer: a multivariate analysis of survival for 100 consecutively treated patients. J Clin Oncol. 1997 Apr;15(4):1309-17. doi: 10.1200/JCO.1997.15.4.1309.
Results Reference
result
PubMed Identifier
7774830
Citation
Stiff P, Bayer R, Camarda M, Tan S, Dolan J, Potkul R, Loutfi S, Kinch L, Sosman J, Peace D, 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. 1995 Jun;57(3):278-85. doi: 10.1006/gyno.1995.1143.
Results Reference
result

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

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