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Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer



Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer

For Condition: adenocarcinoma of the pancreas,recurrent pancreatic cancer
Status: No longer recruiting
Sponsor(s): SuperGen ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine.
Details: OBJECTIVES: I. Compare survival of patients with recurrent or refractory pancreatic cancer after treatment with nitrocamptothecin versus fluorouracil. II. Compare the clinical benefit and objective response rate to these treatment regimens in these patients. III. Compare and evaluate time to treatment failure in these patients with these treatment regimens. IV. Compare the toxicities of these treatment regimens in these patients. PROTOCOL OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive nitrocamptothecin orally on days 1-5. Arm II: Patients receive fluorouracil IV over 30 minutes on day 1. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with tumor regression or stabilization may receive additional courses of treatment. Patients with disease progression or unacceptable toxicity may crossover to the alternate treatment arm. Patients are followed every 3 months for one year. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 15 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed recurrent or refractory adenocarcinoma of the pancreas - Must have received prior gemcitabine and progressed --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy - Chemotherapy: See Disease Characteristics; At least 2 weeks since prior gemcitabine and recovered; No prior chemotherapy except gemcitabine; No other concurrent chemotherapy - Endocrine therapy: No concurrent corticosteroids or hormones - Radiotherapy: No concurrent radiotherapy - Surgery: At least 2 weeks since prior major surgery; No major surgery within 8 weeks following initiation of study treatment --Patient Characteristics-- - Age: Over 18 - Performance status: Karnofsky 50-100% - Life expectancy: At least 2 months - Hematopoietic: Granulocyte count greater than 1,500/mm3; Hemoglobin at least 9 g/dL; Platelet count greater than 100,000/mm3 - Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver); Bilirubin no greater than 2.0 mg/dL - Renal: Creatinine no greater than 2.0 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LawrenceRomel,  Study Chair,  SuperGen

SuperGen, Incorporated
San Ramon,  California,  94583
United States
 


Additional Information:
Study ID Numbers:  CDR0000067907;  SUPERGEN-RFS2000-06,PCI-99-001
Study Start Date: November 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005871

Other Recurrent Pancreatic Cancer Studies:
1. R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

2. Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas

3. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery

4. Perifosine in Treating Patients With Advanced Pancreatic Cancer

5. Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer

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