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Home > "N" Clinical Trials Conditions > Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas  Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
For Condition: recurrent pancreatic cancer,adenocarcinoma of the pancreas
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 other chemotherapy for cancer of the pancreas. PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of other chemotherapy in treating patients who have recurrent or refractory cancer of the pancreas.
Details: OBJECTIVES: I. Compare the overall survival, objective response rate, time to treatment failure, and time to progression in patients with recurrent or refractory adenocarcinoma of the pancreas treated with oral nitrocamptothecin vs most appropriate chemotherapy. II. Compare the toxicity of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified by Karnofsky performance status (50-70% vs greater than 70%). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after week 8 may receive additional courses. Arm II: Patients are stratified by most appropriate therapy possible (mitomycin or investigator's choice (including best supportive care) vs gemcitabine vs fluorouracil). Patients who previously received fluorouracil and gemcitabine with or without radiotherapy receive mitomycin or the investigator's choice of any proven or experimental chemotherapy regimen previously submitted to the sponsor. Patients who previously received fluorouracil only, other chemotherapy only, or fluorouracil with other chemotherapy receive a proven or experimental regimen comprised of gemcitabine. Patients who previously received gemcitabine with other chemotherapy receive a proven or experimental regimen comprised of fluorouracil. Patients with stable or responding disease after week 8 may receive additional courses if medically indicated. Patients for whom these drugs are not indicated may receive best supportive care. At the time of disease progression, patients may receive treatment with nitrocamptothecin. Patients are followed every 3 months for 1 year or until death. PROJECTED ACCRUAL: Approximately 400 patients (200 per 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 proven adenocarcinoma of the pancreas with failure or relapse after at least 1 prior chemotherapy regimen; Ineligible if only prior chemotherapy regimen consisted of gemcitabine alone or fluorouracil as radiosensitizer; No prior nitrocamptothecin or other camptothecin analogs --Prior/Concurrent Therapy-- - Biologic therapy: At least 2 weeks since prior immunotherapy and recovered; No concurrent filgrastim (G-CSF) with nitrocamptothecin; No concurrent immunotherapy - Chemotherapy: See Disease Characteristics; At least 2 weeks since prior chemotherapy and recovered; No other concurrent chemotherapy - Endocrine therapy: No concurrent anticancer hormonal therapy - Radiotherapy: At least 2 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: Greater than 2 weeks since prior surgery and recovered; No planned major surgery within 8 weeks after initiation of treatment --Patient Characteristics-- - Age: Over 18 - Performance status: Karnofsky 50-100% - Life expectancy: At least 8 weeks - Hematopoietic: Granulocyte count greater than 1,500/mm3; Hemoglobin greater than 9 g/dL; Platelet count greater than 100,000/mm3 - Hepatic: SGOT and SGPT no greater than 3 times normal (no greater than 5 times normal if liver tumor present); 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
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000067906; SUPERGEN-RFS2000-09,RPCI-DS-99-11
Study Start Date: March 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005870
Other Recurrent Pancreatic Cancer Studies:
1. Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed
2. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
3. Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
4. Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
5. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
Related Studies:
Other recurrent pancreatic cancer Clinical Trials
Other California Clinical Trials
Other San Ramon Clinical Trials
Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
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