PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT
- Evaluate the feasibility of administering 2 courses of high dose chemotherapy
consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide,
carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and
autologous stem cell support, to patients with advanced carcinomas.
- Describe the toxicity of these high dose chemotherapy regimens.
- Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen.
- Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour
- Determine the disposition of carboplatin administered in the IC-T regimen.
OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection
following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of
chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell
harvest is inadequate.
Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days,
followed the next day by infusion of one fourth of the allotted stem cells, with the
remaining allotment infused 2 days later. G-CSF is given for granulocyte support.
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable
and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5
days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining
allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6
patients are treated with escalating doses of paclitaxel until the maximum tolerated dose
for this regimen is determined.
Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the
physician's discretion for at least 5 years.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied.
Primary Purpose: Treatment
George Somlo, MD
Beckman Research Institute
United States: Federal Government
|City of Hope Comprehensive Cancer Center
|Duarte, California 91010