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| ID | Type | Description | Link |
|---|---|---|---|
| THERADEX-P01-00-03 | |||
| PROTARGA-P01-00-03 | |||
| VMRC-8770 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA-paclitaxel | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed carcinoma of the pancreas
Measurable disease
No islet cell tumors, lymphoma, or sarcoma of the pancreas
No known or clinical evidence of CNS metastasis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
No concurrent serious infection requiring parenteral therapy
No unstable or serious concurrent medical condition
No other prior malignancy except:
No psychiatric disorder that would preclude study compliance
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Ross C. Donehower, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States | ||
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C528070 | docosahexaenoyl-paclitaxel |
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| NYU School of Medicine's Kaplan Comprehensive Cancer Center |
| New York |
| New York |
| 10016 |
| United States |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Kliniken Essen - Mitte | Essen | D-45136 | Germany |
| Krankenhaus Nordwest | Frankfurt | D-60488 | Germany |
| Erasmus Medical Center | Rotterdam | 3008 EA | Netherlands |
| New Cross Hospital | Wolverhampton | England | WV10 0QP | United Kingdom |
| Beatson Oncology Centre | Glasgow | Scotland | G11 6NT | United Kingdom |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |