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

Alternate Title

Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 to 65 Other JHOC-9434 NCI-V94-0544, NCT00002600

Objectives

I. Determine the maximum tolerated dose of carboplatin when combined with 
cyclophosphamide as high-dose therapy followed by autologous bone marrow and 
peripheral blood stem cell rescue in patients with platinum sensitive ovarian 
epithelial carcinoma.

II. Determine the efficacy of this regimen in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed advanced ovarian epithelial malignancy of one of the
following histologies:
 Serous adenocarcinoma
 Endometrioid adenocarcinoma
 Mucinous adenocarcinoma
 Undifferentiated carcinoma
 Clear cell adenocarcinoma
 Mixed epithelial carcinoma

Fallopian tube and extraovarian peritoneal papillary serous tumors also
allowed

Documented responsiveness (using established clinical criteria) to a
platinum-based chemotherapy regimen required

Partial or complete clinical response to the most recent chemotherapy
regimen required

Bone marrow aspirate and biopsy morphologically negative for carcinoma and
cellularity greater than 50%

No CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 See Disease Characteristics
 No more than 2 prior chemotherapy regimens
 At least 4 weeks since prior chemotherapy (at least 6 weeks since prior
  nitrosoureas)

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy for ovarian cancer

Surgery:
 Not specified

Patient Characteristics:

Age:
 18 to 65

Performance status:
 GOG 0-2

Life expectancy:
 Not specified

Hematopoietic:
 WBC greater than 3,000/mm3
 Absolute neutrophil count at least 1,500/mm3
 Platelet count greater than 100,000/mm3

Hepatic:
 Bilirubin less than 1.5 mg/dL*
 SGOT less than 60 IU/mL*
 * Unless abnormality due to metastatic involvement

Renal:
 Creatinine less than 2.0 mg/dL*
 * Unless abnormality due to metastatic involvement
   
Cardiovascular:
 LVEF at least 45% by MUGA scan
 No active congestive heart failure
 No myocardial infarction within the past year
 No active arrhythmia
 No active angina pectoris
 No uncontrolled hypertension

Pulmonary:
 FVC and FEV at least 50% predicted

Other:
 No peripheral neuropathy 
 No uncontrolled diabetes mellitus
 No history of other malignancy except basal cell or squamous cell skin cancer
 No debilitating medical or psychiatric illness that would preclude informed
  consent or study 

Expected Enrollment

A minimum of 18 patients will be accrued for this study within 1 year.

Outline

This is a dose escalation study of carboplatin.

Autologous bone marrow (ABM) is harvested on day -11, filgrastim (G-CSF) is 
administered subcutaneously (SC) on days -11 to -7, and autologous peripheral 
blood stem cells (PBSC) are harvested on day -6.

Patients receive high dose chemotherapy comprising carboplatin IV over 15 
minutes on days -5 and -4 and cyclophosphamide IV over 1 hour on days -3 and 
-2.  PBSC are reinfused on day -1, ABM is reinfused on day 0, and G-CSF is 
administered SC beginning on day 7 and continuing until blood counts recover.  
Cohorts of 2-4 patients receive escalating doses of carboplatin until the 
maximum tolerated dose (MTD) is determined.  The MTD is defined as the 
dose at which no more than 10% of patients experience dose-limiting toxicity.  
A minimum of 6 patients receive carboplatin at the MTD.

Patients are followed at 1 month and then every 3 months for 5 years.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Deborah Armstrong, MD, Protocol chair		Ph: 410-614-2743 Email: darmstro@jhmi.edu

Registry Information
Official Title		A PHASE I TRIAL OF HIGH DOSE CHEMOTHERAPY WITH AUTOLOGOUS BONE MARROW AND PERIPHERAL BLOOD PROGENITOR CELL RESCUE IN PATIENTS WITH PLATINUM-SENSITIVE, CHEMOTHERAPY-RESPONSIVE EPITHELIAL OVARIAN CARCINOMA
Trial Start Date		1994-09-13
Registered in ClinicalTrials.gov		NCT00002600
Date Submitted to PDQ		1994-09-13
Information Last Verified		2001-09-01
NCI Grant/Contract Number		P30-CA06973