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Sponsored by: |
Theradex |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00111904 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: paclitaxel-loaded polymeric micelle |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer |
Estimated Enrollment: | 43 |
Study Start Date: | May 2005 |
OBJECTIVES:
OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed epithelial carcinoma of the pancreas
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for pancreatic cancer
Endocrine therapy
Radiotherapy
More than 6 weeks since prior radiotherapy for pancreatic cancer
Surgery
Other
United States, Florida | |
Florida Cancer Specialists - Bonita Springs | Recruiting |
Bonita Springs, Florida, United States, 34135 | |
Contact: Clinical Trials Office - Florida Cancer Specialists - Bonita S 239-274-9930 | |
United States, Illinois | |
Midwest Cancer Research Group, Incorporated | Recruiting |
Skokie, Illinois, United States, 60077 | |
Contact: K. Joseph Phillip 847-673-1999 ggolden@cancerstudy.com | |
United States, Louisiana | |
Louisiana Oncology Associates - Lafayette | Recruiting |
Lafayette, Louisiana, United States, 70506 | |
Contact: David A. Rinaldi, MD 337-235-7898 davrinald@hotmail.com | |
United States, New York | |
St. Vincent's Comprehensive Cancer Center - Manhattan | Recruiting |
New York, New York, United States, 10011 | |
Contact: Clinical Trials Office - St. Vincent's Comprehensive Cancer Ce 212-367-1729 | |
United States, Texas | |
Southwest Regional Cancer Center - Central | Recruiting |
Austin, Texas, United States, 78705 | |
Contact: Robert O. Kerr, MD 512-421-4141 RKerr@swrcc.com |
Study Chair: | John S. MacDonald, MD | St. Vincent's Comprehensive Cancer Center - Manhattan |
Study ID Numbers: | CDR0000433513, THERADEX-S04-10485, WIRB-20050099 |
Study First Received: | May 26, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00111904 |
Health Authority: | Unspecified |
stage III pancreatic cancer recurrent pancreatic cancer stage IV pancreatic cancer |
Digestive System Diseases Digestive System Neoplasms Paclitaxel Pancreatic Neoplasms Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Recurrence Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |