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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-57100 | |||
| NCI-5332 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
OBJECTIVES:
OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks.
Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | |||
| irinotecan hydrochloride | Drug | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur William Blackstock, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16062075 | Result | Mishra G, Butler J, Ho C, Melin S, Case LD, Ennever PR, Magrinat GC, Bearden JD, Minotto DC, Howerton R, Levine E, Blackstock AW. Phase II trial of induction gemcitabine/CPT-11 followed by a twice-weekly infusion of gemcitabine and concurrent external beam radiation for the treatment of locally advanced pancreatic cancer. Am J Clin Oncol. 2005 Aug;28(4):345-50. doi: 10.1097/01.coc.0000159559.42311.c5. |
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| Southeastern Medical Oncology Center |
| Goldsboro |
| North Carolina |
| 27534 |
| United States |
| East Carolina University School of Medicine | Greenville | North Carolina | 27858-4354 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Spartanburg Regional Healthcare System | Spartanburg | South Carolina | 29303 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077146 | Irinotecan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D013812 | Therapeutics |
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