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Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer Clinical research trials and Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer. Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer  Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,adenocarcinoma of the pancreas,stage 2 pancreatic cancer,stage 1 pancreatic cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of combining cisplatin, fluorouracil, and interferon alfa with radiation therapy in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.
Details: OBJECTIVES: Primary - Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy. - Determine the toxic effects of this regimen in these patients. Secondary - Determine the disease-specific, biochemical failure-free, and symptom/treatment-free survival of patients treated with this regimen. - Determine the quality of life of patients treated with this regimen. OUTLINE: - Chemoradiotherapy: Patients receive fluorouracil IV continuously and interferon alfa subcutaneously 3 times per week (total of 17 doses) on days 1-21 and 29-45 and cisplatin IV over 1 hour on days 1, 8, 15, 29, 36 and 43. Patients also undergo concurrent radiotherapy once daily, 5 days a week, over 5.5 weeks (28 fractions). - Post-chemoradiotherapy fluorouracil: Patients receive fluorouracil IV continuously on days 71-108 and 127-168. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic adenocarcinoma of the pancreatic head or uncinate process - Stage I, II, or III - Completely resected disease (R0 or R1) - Postoperative CA 19-9 less than 100 - Study treatment must begin within 12 weeks of surgery - Postoperative CT scan without evidence of radiographically definable residual primary/metastatic disease or clinically significant postsurgical changes PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - WBC greater than 3,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 75,000/mm^3 - Hemoglobin greater than 9.0 g/dL Hepatic - Not specified Renal - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min - Bilateral renal function by excretory urogram (IVP) or abdominal CT scan OR at least 2/3 of 1 functioning kidney must be able to be shielded from the radiotherapy beam Cardiovascular - No significant cardiovascular disease - No unstable angina - No congestive heart failure Pulmonary - No severe pulmonary disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - Prior history of non-pancreatic malignancy allowed at the discretion of the study chair provided patient is free of the primary cancer - No concurrent acute infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterPisters, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Peter Pisters 713-794-1572
Additional Information:
Study ID Numbers: CDR0000327752; MDA-ID-02040
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068575
Other Stage 1 Pancreatic Cancer Studies:
1. Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer
2. Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
3. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
4. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
5. Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer
Related Studies:
Other stage 1 pancreatic cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
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