High Dose Chemotherapy With Stem Cell Rescue in Recently Diagnosed Patients With Advanced (Stage III and IV) Ovarian Cancer With > 1 cm Residual Disease After Debulking Surgery


Phase 2
18 Years
70 Years
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

High Dose Chemotherapy With Stem Cell Rescue in Recently Diagnosed Patients With Advanced (Stage III and IV) Ovarian Cancer With > 1 cm Residual Disease After Debulking Surgery


OBJECTIVES: I. Evaluate the complete response rates, event free survival, and overall
survival of patients with recently diagnosed stage III or IV ovarian epithelial cancer
receiving carmustine plus melphalan followed by consolidation therapy after having undergone
surgical debulking. II. Evaluate the therapy related mortality associated with the
autotransplant and the consolidation therapy in these patients. III. Evaluate the quality of
life in this patient population.

OUTLINE: Patients are stratified by stage (III vs IV) and volume of residual disease (less
than 3 cm vs at least 3 cm). Approximately 10-15 days after surgery, patients receive
filgrastim (G-CSF) subcutaneously daily until all peripheral blood stem cell (PBSC)
collections have been completed. Patients then receive carmustine IV over 2 hours on day -2
and melphalan IV over 20 minutes on day -1. Peripheral blood stem cells are infused 24 hours
after melphalan on day 0. Patients receive G-CSF subcutaneously beginning on day 6 and
continuing until granulocytes have recovered. Three months after the PBSC infusion, patients
receive consolidation therapy with paclitaxel IV over 6 hours on day 2 and cisplatin IV over
24 hours on day 3. Consolidation treatment is repeated every 3 months for a total of 4
courses. Quality of life questionnaires are completed prior to PBSC transplant, before
discharge after transplant, before each consolidation treatment, and 3 months after the last
consolidation course. Patients are followed at least every 3 months for the first 2 years,
and then every 6 months thereafter.

PROJECTED ACCRUAL: An estimated 32 patients will be accrued into this study over 3-4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial
cancer who have undergone surgical debulking Stage III patients must have greater than 1
cm residual mass after surgery Must have had no more than 1 course of platinum based
chemotherapy No CNS disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL
Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or
liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF at least
50% Pulmonary: FVC, FEV1, and corrected DLCO at least 50% of predicted If unable to
complete pulmonary function tests due to pain related to the recent surgery, patient must
have a high resolution CT scan of the chest and acceptable arterial blood gases (PO2 at
least 70) Other: HIV negative No active infection requiring intravenous antibiotics Not
pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See
Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sandra E. Brooks, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066426

NCT ID:

NCT00003413

Start Date:

September 1998

Completion Date:

February 2001

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201