Brief Title
Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
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
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Bone marrow transplantation and peripheral stem cell
transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with
carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell
transplantation in treating patients who have advanced ovarian epithelial cancer.
Detailed Description
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.
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.
PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 1 year.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
filgrastim
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
23
Start Date
October 21, 1994
Completion Date
July 25, 2001
Primary Completion Date
July 25, 2001
Eligibility 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
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
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
Gender
Female
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Deborah K. Armstrong, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00002600
Organization ID
J9434
Secondary IDs
CDR0000063839
Responsible Party
Sponsor
Study Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor
Deborah K. Armstrong, MD, Study Chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date
September 2001