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


Phase 2
N/A
64 Years
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Patrick J. Stiff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University

Authority:

United States: Federal Government

Study ID:

LUMC-3007

NCT ID:

NCT00002474

Start Date:

February 1991

Completion Date:

October 2005

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500