Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
|ClinicalTrials.gov Identifier: NCT00005599|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 21, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: bryostatin 1 Drug: paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer|
|Study Start Date :||February 2000|
|Study Completion Date :||August 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005599
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10467|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Gary K. Schwartz, MD||Memorial Sloan Kettering Cancer Center|