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| Sponsor: | 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 |
| 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 | |
| Study Chair: | Ross C. Donehower, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068926, THERADEX-P01-00-03, PROTARGA-P01-00-03, VMRC-8770 |
| Study First Received: | September 13, 2001 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00024375 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent pancreatic cancer stage IV pancreatic cancer |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Mitosis Modulators Endocrine System Diseases Antimitotic Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Digestive System Diseases Paclitaxel Therapeutic Uses Tubulin Modulators Pancreatic Diseases Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |