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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-99094 | |||
| MSKCC-FDR001826 | |||
| NCI-250 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bryostatin 1 | Drug | |||
| paclitaxel | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction
Locally advanced and considered surgically unresectable or metastatic
Measurable disease
Accurately measured in at least 1 dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
No truly nonmeasurable lesions only:
No brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study participation
No preexisting neurotoxicity of grade 3 or greater
No serious concurrent infection or nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
No concurrent psychiatric disorders that would preclude study compliance
No other active malignancy within the past 5 years except:
HIV negative
No other concurrent medical condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Gary K. Schwartz, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States | ||
| Albert Einstein Clinical Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18270704 | Result | Ku GY, Ilson DH, Schwartz LH, Capanu M, O'Reilly E, Shah MA, Kelsen DP, Schwartz GK. Phase II trial of sequential paclitaxel and 1 h infusion of bryostatin-1 in patients with advanced esophageal cancer. Cancer Chemother Pharmacol. 2008 Oct;62(5):875-80. doi: 10.1007/s00280-008-0677-y. Epub 2008 Feb 13. |
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| The Bronx |
| New York |
| 10467 |
| United States |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| C046785 | bryostatin 1 |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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