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| Sponsored by: |
Theradex |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024375 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|
Pancreatic Cancer |
Drug: DHA-paclitaxel |
Phase II |
| MedlinePlus related topics: | Cancer Pancreatic Cancer |
| Drug Information available for: | Paclitaxel DHA-paclitaxel Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas |
| Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 courses, and at completion of treatment.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed carcinoma of the pancreas
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
No other prior malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
| Baltimore, Maryland, United States, 21231-2410 | |||||
| United States, New York | |||||
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |||||
| New York, New York, United States, 10016 | |||||
| United States, Pennsylvania | |||||
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |||||
| Philadelphia, Pennsylvania, United States, 19107-5541 | |||||
| United States, Washington | |||||
| Virginia Mason Medical Center | |||||
| Seattle, Washington, United States, 98101 | |||||
| Germany | |||||
| Kliniken Essen - Mitte | |||||
| Essen, Germany, D-45136 | |||||
| Krankenhaus Nordwest | |||||
| Frankfurt, Germany, D-60488 | |||||
| Netherlands | |||||
| Erasmus Medical Center | |||||
| Rotterdam, Netherlands, 3008 EA | |||||
| United Kingdom, England | |||||
| New Cross Hospital | |||||
| Wolverhampton, England, United Kingdom, WV10 0QP | |||||
| United Kingdom, Scotland | |||||
| Beatson Oncology Centre | |||||
| Glasgow, Scotland, United Kingdom, G11 6NT | |||||
| Theradex |
| Study Chair: | Ross C. Donehower, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068926, THERADEX-P01-00-03, PROTARGA-P01-00-03, VMRC-8770 |
| First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00024375 |
| Health Authority: | United States: Federal Government |
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