Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TARGET-S04-10485 | |||
| WIRB-20050099 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel-loaded polymeric micelle | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | ||
| Time to treatment failure | ||
| Best overall response rate | ||
| Overall survival | ||
| Clinical benefit | ||
| Safety |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed epithelial carcinoma of the pancreas
No known or clinical evidence of CNS metastasis
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John S. MacDonald, MD | Beth Israel Comprehensive Cancer Center - West Side Campus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists - Bonita Springs | Bonita Springs | Florida | 34135 | United States | ||
| Midwest Cancer Research Group, Incorporated |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19968498 | Result | Saif MW, Podoltsev NA, Rubin MS, Figueroa JA, Lee MY, Kwon J, Rowen E, Yu J, Kerr RO. Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer. Cancer Invest. 2010 Feb;28(2):186-94. doi: 10.3109/07357900903179591. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000708971 | genexol-PM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Skokie |
| Illinois |
| 60077 |
| United States |
| Louisiana Oncology Associates - Lafayette | Lafayette | Louisiana | 70506 | United States |
| St. Vincent's Comprehensive Cancer Center - Manhattan | New York | New York | 10011 | United States |
| Southwest Regional Cancer Center - Central | Austin | Texas | 78705 | United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |