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

May 29, 2013 updated by: Loyola University

Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate
Overall survival
Response duration
Nonhematopoietic toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1991

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUMC-3007
  • CDR0000076845 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-V91-0058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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