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
filgrastim
+ carmustine
+ cisplatin
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: September 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, United StatesOpen Marlene & Stewart Greenebaum Cancer Center, University of Maryland in Google Maps