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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 Stage 4b Pancreatic Cancer Studies:
1. Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

2. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

3. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

4. Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

5. Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer

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R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

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