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| Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031694 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: bryostatin 1 Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Sequential Paclitaxel And Bryostatin-1 For Patients With Advanced Pancreatic Cancer |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No history of significant ventricular arrhythmia requiring antiarrhythmics
Other:
No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No more than 2 courses of prior standard cytotoxic chemotherapy for pancreatic cancer, including any of the following:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10467 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Andreas Kaubisch, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
| Study ID Numbers: | CDR0000069216, AECM-019224, NCI-5624 |
| Study First Received: | March 8, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00031694 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Adjuvants, Immunologic Endocrine System Diseases Antimitotic Agents Bryostatin 1 Pancrelipase Recurrence |
Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Mitosis Modulators Physiological Effects of Drugs Adjuvants, Immunologic Endocrine System Diseases Antimitotic Agents Bryostatin 1 |
Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Paclitaxel Therapeutic Uses Tubulin Modulators Pancreatic Diseases Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |