A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Optimally Debulked Stage III Ovarian Carcinoma
- Determine the safety and feasibility of multiple courses of high dose carboplatin,
paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral
blood stem cell transplantation in patients with optimally debulked stage III ovarian
or primary peritoneal carcinoma.
- Determine the pathological complete response rate, disease free survival, and overall
survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive
cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours.
Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after
completion of paclitaxel infusion and continuing until blood counts recover and
autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+
- High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients
receive paclitaxel IV over 24 hours beginning on day 1, immediately followed by
carboplatin IV over 2 hours, immediately followed by topotecan IV over 24 hours.
Patients receive G-CSF SQ daily beginning 24 hours after completion of topotecan
infusion and continuing until blood counts have recovered for 2 days. One quarter of
the PBSC are reinfused beginning 2 days after completion of topotecan infusion.
Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or
Patients with radiographic and biochemical complete response undergo laparoscopy as second
look surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is
found during laparoscopy, then exploratory laparotomy must also be performed.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter or at time of recurrence until death.
PROJECTED ACCRUAL: A total of 20-41 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Russell J. Schilder, MD
Fox Chase Cancer Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Chao Family Comprehensive Cancer Center||Orange, California 92868|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Cooper Hospital/University Medical Center||Camden, New Jersey 08103|
|Barrett Cancer Center, The University Hospital||Cincinnati, Ohio 45219|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Holden Comprehensive Cancer Center at The University of Iowa||Iowa City, Iowa 52242-1009|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|