A Phase II Trial of High Dose Paclitaxel, Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer
OBJECTIVES: I. Evaluate one year progression free survival, complete response rate, and
overall survival in patients with metastatic small cell cancer treated with high dose
paclitaxel, carboplatin, and topotecan with peripheral blood stem cell support. II. Assess
the safety of this treatment regimen in this patient population.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour, followed by paclitaxel IV over 24
hours on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing
through the day prior to the last collection day. Peripheral blood stem cells (PBSC) are
collected over 3-5 days. Beginning approximately 21 days following mobilization, patients
receive paclitaxel IV over 24 hours on day 1, immediately followed by carboplatin IV over 2
hours and topotecan IV over 24 hours on day 2, then G-CSF subcutaneously beginning on day 4
and continuing until blood counts recover. PBSC are reinfused on day 5. Patients receive 1/3
of PBSC with each course. Treatment repeats every 4 weeks for 3 courses in the absence of
unacceptable toxicity. Patients are followed at week 8 after treatment, then every 3 months
for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the one year progression-free survival
Russell J. Schilder, MD
Fox Chase Cancer Center
United States: Federal Government
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|