Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer
OBJECTIVES:
- Determine the complete and partial response rates in patients with unresectable or
metastatic esophageal cancer or carcinoma of the gastroesophageal junction treated with
sequential paclitaxel and bryostatin 1.
- Determine the toxicity of this regimen in this patient population.
- Determine the survival of patients after treatment with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Examine pre- and post-treatment tissue biopsies for markers of apoptosis in selected
patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day
2 weekly for 2 weeks. Courses repeat every 28 days in the absence of unacceptable toxicity
or disease progression.
Quality of life is assessed at baseline, after courses 1 and 2, and then after every 2
courses thereafter.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 1-2
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Gary K. Schwartz, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000067712
NCT00005599
February 2000
August 2004
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |