Ovarian Cancer Clinical Trial
Official title:
Phase I-II Study of Tandem Cycles of High Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Support in Women With Persistent, Refractory or Recurrent Advanced (Stage III or IV), Epithelial Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy and kill more
tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous
peripheral stem cell transplantation in treating patients with recurrent or persistent
epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.
OBJECTIVES:
- Determine the maximum tolerated dose of topotecan with a fixed dose of etoposide
phosphate as a component of a multicourse high dose chemotherapy regimen supported by
peripheral blood stem cell transplantation in patients with persistent or recurrent
ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Evaluate the response, time to progression, disease free survival, and overall survival
in this patient population.
OUTLINE: This is a dose escalation study of topotecan.
All patients receive induction therapy consisting of 1 to 2 courses of mobilization therapy.
Subcutaneous filgrastim (G-CSF) is given beginning 24 hours after induction dose. Following
induction therapy, peripheral blood stem cells (PBSC) are harvested. After patients receive
high dose paclitaxel and carboplatin chemotherapy, a portion of the PBSC are reinfused. When
patients recover from the paclitaxel/carboplatin chemotherapy the administration of
topotecan and etoposide phosphate begins. Topotecan is administered, as a 72 hour continuous
infusion, according to a dose escalation schedule with a fixed dose of etoposide phosphate.
A second portion of PBSC are reinfused after topotecan/etoposide phosphate chemotherapy. A
course of thiotepa is given along with the final portion of PBSC after treatment with
topotecan and etoposide phosphate.
Dose escalation of topotecan continues until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 or more patients experience dose
limiting toxicity.
Patients are followed every 3 months for 1 year and every 4 months thereafter to determine
progression free and overall survival.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for the phase I portion of
this study, and 25 more patients will be accrued for the phase II portion.
;
Primary Purpose: Treatment
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