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| ID | Type | Description | Link |
|---|---|---|---|
| UAB-9915 | Other Grant/Funding Number | 0001215 | |
| ISIS-2503-CS5 | |||
| UAB-F990526011 | |||
| NCI-G00-1730 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Ionis Pharmaceuticals, Inc. | INDUSTRY |
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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 ISIS 2503 in treating patients who have advanced cancer of the pancreas.
OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of response in these patients receiving this regimen. III. Characterize the safety profile of ISIS 2503 at the recommended phase II dose and schedule in these patients.
OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every 21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISIS 2503 | Experimental | All patients will begin treatment at a dose of 6 mg/kg/day of ISIS 2503. ISIS 2503 at the assigned dose will be given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. No drug will be administered during the third week of each treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISIS 2503 | Drug | Beginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule. | 24 weeks |
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DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the pancreas that is considered inoperable Measurable disease with at least 1 lesion measuring at least 2 cm in widest diameter identifiable on CT or MRI scan
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 6 months after study No underlying disease state associated with active bleeding No active infection requiring therapy No other prior malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy for pancreatic cancer Chemotherapy: No prior chemotherapy for pancreatic cancer except for fluorouracil and/or gemcitabine administered as a radiosensitizer No other concurrent chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed provided indicator lesions not within prior radiation port Recovered from toxicity No concurrent radiotherapy for pancreatic cancer Surgery: See Disease Characteristics Other: No concurrent anticoagulation therapy with heparin No other concurrent approved or experimental cancer therapy
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| Name | Affiliation | Role |
|---|---|---|
| James A. Posey, MD | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Norris Cotton Cancer Center |
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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 |
|---|---|
| C122000 | ISIS 2503 |
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| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |