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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


Phase 1/Phase 2
N/A
65 Years
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

David L. Grinblatt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

8433

NCT ID:

NCT00003136

Start Date:

December 1996

Completion Date:

October 2001

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637