| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-02040 | Other Identifier | UT MD Anderson Cancer Center | |
| CDR0000327752 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Schering-Plough | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative Chemoradiation Regimen | Experimental | Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Interferon Alfa | Biological | 3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) | Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death. | Participants followed till disease progression or death (approximately 6 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter W. Pisters, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
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| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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Of the 29 participants who were enrolled, one patient dropped out prior to receiving study treatment.
Recruitment Period: May 31, 2002 to January 14, 2010. All recruitment was done at UT MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Postoperative Chemoradiation Regimen | Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cisplatin | Drug | 30 mg/m^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy. |
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| Fluorouracil | Drug | 175 mg/m^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168. |
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| Radiation Therapy | Radiation | External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Postoperative Chemoradiation Regimen | Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Overall Survival (OS) | Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death. | Analysis by protocol. | Posted | Median | 95% Confidence Interval | months | Participants followed till disease progression or death (approximately 6 years) |
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Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Postoperative Chemoradiation Regimen | Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment. | 25 | 28 | 0 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
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| Febrile (Non-neutropenic) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Elevated alkaline phosphate | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Elevated Alanine transaminase (ALT) | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Abdominal Pain | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Hand/foot syndrome | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Mucositis/Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Abdominal abscess | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Overdose of interferon alfa-2b (IFN) | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Pisters, MD / Professor | UT MD Anderson Cancer Center | asanmigu@mdanderson.org |
| 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 |
|---|---|
| D016898 | Interferon-alpha |
| D000077190 | Interferon alpha-2 |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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