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R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical research trials and R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer. R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer clinical trial. Participants typically obtain the most effective healthcare available for their R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
For Condition: childhood gastrointestinal cancer,stage 4B pancreatic cancer,stage 2 pancreatic cancer,stage 3 pancreatic cancer,adenocarcinoma of the pancreas,stage 4A pancreatic cancer,duct cell adenocarcinoma of the pancreas
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group
Synopsis: 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 R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.
Details: OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients. PROTOCOL OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed adenocarcinoma of the pancreas; Ductal adenocarcinoma; Mucinous noncystic carcinoma Signet ring cell carcinoma; Adenosquamous carcinoma; Undifferentiated (anaplastic) carcinoma; Mixed ductal endocrine carcinoma; Well differentiated adenocarcinoma; Moderately well or poorly differentiated adenocarcinoma; Undifferentiated ductal carcinoma - No papillary cystic carcinomas, sarcomas, or tumors arising from the endocrine pancreas - Pathological confirmation of a metastatic site allowed; Clinical documentation of pancreatic involvement and no evidence of another primary allowed - Locally advanced or distant metastatic disease surgically incurable - No known brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior or concurrent immunotherapy - Chemotherapy: No prior chemotherapy; No prior adjuvant or neoadjuvant chemoradiotherapy, including for advanced pancreatic cancer; No other concurrent chemotherapy - Endocrine therapy: No prior or concurrent hormonal therapy - Radiotherapy: See Chemotherapy; No prior radiotherapy, except for palliation to metastatic sites; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 2 weeks since prior surgery for pancreatic cancer and recovered; Prior partial resections of the stomach and duodenum for pancreatic cancer allowed; No prior major resection of the small intestine; Prior pancreaticduodenectomy for pancreatic cancer allowed - Other: No concurrent proton pump inhibitors (e.g., omeprazole); Concurrent antacids or H2 blockers allowed; No other concurrent therapy for pancreatic cancer --Patient Characteristics-- - Age: Not specified - Performance status: Zubrod 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Other: Ability to swallow and/or receive enteral medications via gastrostomy feeding tube; No intractable nausea or vomiting; No other prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnMacdonald, Study Chair, Southwest Oncology Group
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Additional Information:
Study ID Numbers: CDR0000067846; SWOG-S9924
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005832
Other Adenocarcinoma Of The Pancreas Studies:
1. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery
2. Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
3. Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
4. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
5. UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other Texas Clinical Trials
Other Galveston Clinical Trials
R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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