Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer or Primary Peritoneal Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer; Peritoneal Cavity Cancer
Intervention: amifostine trihydrate (Drug); carboplatin (Drug); cyclophosphamide (Drug); filgrastim (Drug); biological therapy (Procedure); bone marrow ablation with stem cell support (Procedure); chemoprotection (Procedure); chemotherapy (Procedure); colony-stimulating factor therapy (Procedure); cytokine therapy (Procedure); peripheral blood stem cell transplantation (Procedure); supportive care/therapy (Procedure)
Phase: Phase 1/Phase 2
Status: No longer recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
David L. Grinblatt, MD, Study Chair, Affiliation: University of Chicago
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine, carboplatin and cyclophosphamide, followed by peripheral stem cell transplantation, in treating patients with epithelial ovarian cancer or primary peritoneal cancer.
Clinical Details
Official title:
A Phase I/II Dose Escalation Trial of Carboplatin With Amifostine Pretreatment to Augment High Dose Cyclophosphamide With Autologous Peripheral Blood Stem Cell Support for the Treatment of Patients With Epithelial Ovarian Cancer
Study design: Interventional, Treatment
Detailed description:
OBJECTIVES: I. Determine the maximum tolerated dose of high dose carboplatin with a fixed dose of high dose cyclophosphamide with amifostine pretreatment, and peripheral blood stem cell rescue in patients with ovarian epithelial cancer. II. Monitor engraftment kinetics such as granulocyte and platelet recovery. III. Determine the toxic effects of this regimen in this patient population. IV. Document the response of this patient population to this regimen in terms of time to progression, event free survival, and overall survival.
OUTLINE: This is a dose escalation study. Patients undergo apheresis over 2-4 days to mobilize peripheral blood stem cells (PBSC). They then receive amifostine IV over 15 minutes. Fifteen minutes later, carboplatin is administered over 30 minutes on days - 6 through -3. Cyclophosphamide IV is administered 1 hour after the carboplatin infusion is completed on days -6 through -4. PBSC are infused on day 0. Filgrastim (G-CSF) is administered beginning on day 4. Cohorts of 3-6 patients are treated at each dose level. At least 15 days must pass between the day of PBSC infusion and the next dose escalation. The dose limiting toxicity (DLT) is defined as the dose producing grade 3 or 4 nonhematologic toxicity in 2 of 6 patients. The maximum tolerated dose (MTD) is defined as one dose level below the DLT dose. At least 6 patients are treated at the MTD. Patients are followed monthly for 6 months, every 2-3 months for 1 year, and annually until death.
PROJECTED ACCRUAL: This study will accrue 28 patients over 2 years.
Eligibility
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
DISEASE CHARACTERISTICS: Histologically proven ovarian epithelial cancer or primary peritoneal carcinoma No tumors of low malignant potential Chemotherapy sensitive disease Relapse greater than 6 months after complete response to chemotherapy Partial response to most recent chemotherapy No more than 3 prior chemotherapy regimens Evidence of refractory or recurrent disease other than elevated CA-125 after primary surgery or chemotherapy; persistent disease need not be still present No brain metastases
PATIENT CHARACTERISTICS: Age: 65 and under Performance status: GOG 0 or 1 Life expectancy: Not specified Hematopoietic: WBC greater than 2500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal Renal: Creatinine clearance at least 50 mL/min Cardiovascular: Normal radionuclide cardiac scan with ejection fraction greater than 45% OR Normal left ventricular function by echocardiogram OR Cardiac clearance by Cardiology service Pulmonary: DLCO greater than 50% predicted Other: Not pregnant Hepatitis B and C negative HIV-1 negative
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Locations and Contacts
University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
December 1996
Last updated: February 20, 2007
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