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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002474
First received: November 1, 1999
Last updated: May 29, 2013
Last verified: March 2003
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Nonhematopoietic toxicity [ Designated as safety issue: Yes ]

Study Start Date: February 1991
Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   up to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002474

Locations
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
Sponsors and Collaborators
Loyola University
Investigators
Study Chair: Patrick J. Stiff, MD Loyola University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002474     History of Changes
Other Study ID Numbers: LUMC-3007, CDR0000076845, NCI-V91-0058
Study First Received: November 1, 1999
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cyclophosphamide
Mitoxantrone
Carboplatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014