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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery  Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery
For Condition: recurrent pancreatic cancer,stage 4B pancreatic cancer,stage 3 pancreatic cancer,stage 4A pancreatic cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Barbara Ann Karmanos Cancer Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by surgery.
Details: OBJECTIVES: I. Determine the overall survival in patients with unresectable stage III or IV pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. II. Determine the resectability rate with curative intent in patients with unresectable stage III pancreatic adenocarcinoma treated with this regimen. III. Assess the tolerability and toxicity of this treatment regimen in this patient population. IV. Evaluate this regimen in terms of response rate, response duration, and overall time to disease progression in these patients. V. Evaluate the quality of life in these patients. PROTOCOL OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, followed by cisplatin IV over 30 minutes on days 1 and 15. Patients receive fluorouracil as a continuous infusion on days 1-15. Courses repeat every 28 days. Quality of life is assessed every 28 days. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed pancreatic adenocarcinoma; Unresectable locally advanced (stage III) OR Metastatic (stage IV); Gallbladder or biliary tract cancer allowed - No endocrine tumors or lymphoma of the pancreas - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for locally advanced or metastatic disease; At least 6 months since prior adjuvant chemotherapy; No prior gemcitabine - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Adult - Performance status: SWOG 0-2 - Life expectancy: At least 12 weeks - 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; AST no greater than 3.0 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: No active infection; No other serious systemic disorders; No other active malignancies within the past year except curatively treated basal cell skin cancer or carcinoma in situ of the cervix; Must have central venous access device (i.e., Infusaport or PASPORT); Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PhilipPhilip, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Additional Information:
Study ID Numbers: CDR0000067213; WSU-D-1993,NCI-G99-1553,WSU-04-03-99-M01-FB
Study Start Date: April 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004003
Other Stage 4b Pancreatic Cancer Studies:
1. Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
2. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
3. Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
4. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
5. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery
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