A Phase I Trial of Irinotecan, Radiation Therapy and Escalating Doses of Docetaxel With Cisplatin in Locally Advanced Esophageal Cancer
OBJECTIVES:
Primary
- To determine the dose limiting toxicity and recommended phase II dose of docetaxel when
given at escalating doses with weekly irinotecan hydrochloride and concurrent
radiotherapy in patients with locally advanced esophageal cancer.
- To determine the dose limiting toxicity of cisplatin, once the recommended phase II
dose of docetaxel is established, when given weekly with docetaxel, irinotecan
hydrochloride, and concurrent radiotherapy in patients with locally advanced esophageal
cancer.
Secondary
- To evaluate the clinical and pathological complete response rate in patients with
locally advanced esophageal cancer treated with induction chemotherapy comprising
docetaxel and irinotecan hydrochloride with or without cisplatin followed by concurrent
docetaxel and irinotecan hydrochloride with or without cisplatin plus radiotherapy.
OUTLINE: Patients receive one of the following regimens. Regimen 2 is for patients recruited
after the recommended phase II dose has been determined in patients recruited (who receive
regimen 1).
- Regimen 1:
- Induction chemotherapy (weeks 1-6): Patients receive docetaxel IV over 15 minutes
and irinotecan hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats
every 3 weeks for 2 courses in the absence of disease progression or unacceptable
toxicity.
- Chemoradiotherapy (weeks 8-13): Beginning in week 8, patients receive docetaxel IV
over 15 minutes and irinotecan hydrochloride IV over 30 minutes on days 1 (week 8)
and 8 (week 9). Patients also undergo radiotherapy once daily, 5 days a week, in
weeks 8-10. Treatment with chemoradiotherapy repeats every 3 weeks for 2 courses
in the absence of disease progression or unacceptable toxicity.
- Regimen 2:
- Induction chemotherapy (weeks 1-6): Patients receive docetaxel IV and irinotecan
hydrochloride as in regimen 1 induction chemotherapy. They also receive cisplatin
IV over 20-30 minutes on days 1 and 8. Treatment with irinotecan hydrochloride,
docetaxel, and cisplatin repeats every 3 weeks for 2 courses in the absence of
disease progression or unacceptable toxicity.
- Chemoradiotherapy (weeks 8-13): Patients receive docetaxel IV, irinotecan
hydrochloride IV, and undergo radiotherapy as in regimen 1 chemoradiotherapy.
Patients also receive cisplatin IV over 20-30 minutes on days 1 (week 8) and 8
(week 9). Treatment with irinotecan hydrochloride, docetaxel, cisplatin, and
radiotherapy repeats every 3 weeks for 2 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of docetaxel when administered together with irinotecan hydrochloride and radiotherapy
2 years
Yes
David H. Ilson, MD, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
02-061
NCT00601692
April 2003
December 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |