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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


Phase 1
18 Years
65 Years
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Deborah K. Armstrong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000063839

NCT ID:

NCT00002600

Start Date:

September 1994

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201