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.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer peritoneal cavity cancer	Drug: amifostine  Drug: carboplatin  Drug: cyclophosphamide  Drug: filgrastim	Phase I Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  up to  65 Years

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• See Disease Characteristics

--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

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States

Study chairs or principal investigators

David L. Grinblatt,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000065904; UCCRC-8433; NCI-V97-1357; ALZA-97-005-ii
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003136
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08