Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
Study Details
Study Description
Brief Summary
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 |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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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.
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Determine the toxicity of this regimen in this patient population.
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Determine the survival of patients after treatment with this regimen.
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Determine the quality of life of patients treated with this regimen.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction
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If tumor extends below GE junction into the proximal stomach, 50% of the tumor must involve the esophagus or GE junction
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No gastric cancer with only a minor involvement of GE junction or distal esophagus
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Locally advanced and considered surgically unresectable or metastatic
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Measurable disease
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Accurately measured in at least 1 dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
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No truly nonmeasurable lesions only:
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Bone lesions
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Leptomeningeal disease
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Ascites
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Pleural/pericardial effusions
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Inflammatory breast disease
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Lymphangitis cutis/pulmonis
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Abdominal masses not confirmed and followed by imaging techniques
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Cystic lesions
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No brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
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Granulocyte count at least 1,500/mm^3
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Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
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No history of active angina
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No myocardial infarction within the past 6 months
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No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
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Well-controlled atrial fibrillation on standard management allowed
Pulmonary:
- DLCO at least 60%
Other:
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception during and for 2 months after study participation
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No preexisting neurotoxicity of grade 3 or greater
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No serious concurrent infection or nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
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No concurrent psychiatric disorders that would preclude study compliance
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No other active malignancy within the past 5 years except:
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Nonmelanoma skin cancer
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Carcinoma in situ of the cervix
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History of T1a or b prostate cancer (detected incidentally at transurethral resection of prostate [TURP] and comprising less than 5% of resected tissue) provided prostate-specific antigen remained normal since TURP removal
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HIV negative
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No other concurrent medical condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
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Recovered from prior chemotherapy
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No more than 1 prior neoadjuvant or adjuvant regimen for esophageal cancer
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No prior taxanes for esophageal cancer
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No prior bryostatin 1 for esophageal cancer
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No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
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Prior radiotherapy allowed provided recent evidence of disease progression if indicator lesion is within prior radiation field
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Recovered from prior radiotherapy
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No concurrent radiotherapy
Surgery:
- Not specified
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Albert Einstein Clinical Cancer Center | Bronx | New York | United States | 10467 |
2 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Gary K. Schwartz, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000067712
- MSKCC-99094
- MSKCC-FDR001826
- NCI-250