Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Closed	65 and under	Pharmaceutical / Industry	UCCRC-8433 ALZA-97-005-ii, NCI-V97-1357, NCT00003136

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.

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

Expected Enrollment

This study will accrue 28 patients over 2 years.

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

David Grinblatt, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-9200; 888-824-0200

Registry Information
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
Trial Start Date		1996-12-01
Registered in ClinicalTrials.gov		NCT00003136
Date Submitted to PDQ		1997-11-07
Information Last Verified		2006-05-19

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