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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002474
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin Drug: cyclophosphamide Drug: mitoxantrone hydrochloride Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
Study Start Date : February 1991
Actual Study Completion Date : October 2005

Primary Outcome Measures :
  1. Response rate
  2. Response duration
  3. Overall survival
  4. Nonhematopoietic toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 64 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Under 65

Performance status:

  • SWOG 0-2

Life expectancy:

  • At least 8 weeks


  • WBC greater than 3,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10.0 g/dL


  • Bilirubin less than 2.0 mg/dL
  • SGOT and SGPT less than 2 times upper limit of normal


  • Creatinine clearance greater than 60 mL/min
  • No prior hemorrhagic cystitis


  • LVEF greater than 45% by MUGA scan


  • 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


Biologic therapy:

  • See Disease Characteristics
  • No prior bone marrow transplantation
  • More than 4 weeks since other prior biologic therapy and recovered


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • Not specified


  • More than 4 weeks since prior radiotherapy and recovered


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002474

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United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
Sponsors and Collaborators
Loyola University
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Study Chair: Patrick J. Stiff, MD Loyola University
Publications of Results:
Layout table for additonal information Identifier: NCT00002474    
Other Study ID Numbers: LUMC-3007
CDR0000076845 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: March 2003
Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Sensory System Agents
Peripheral Nervous System Agents