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Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer Clinical research trials and Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer. Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer  Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
For Condition: stage 2 pancreatic cancer,stage 3 pancreatic cancer,stage 4B pancreatic cancer,recurrent pancreatic cancer,adenocarcinoma of the pancreas,stage 4A 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 gemcitabine for pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with gemcitabine in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
Details: OBJECTIVES: I. Compare the overall survival, time to treatment failure, clinical benefit response rate (analgesic consumption, pain intensity, performance status, and weight change), and objective response rate in chemotherapy naive patients with unresectable locally advanced or metastatic adenocarcinoma of the pancreas treated with oral nitrocamptothecin vs gemcitabine. II. Compare the toxicity of these 2 regimens in these patients. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to measurable disease (yes vs no), Karnofsky performance status (50-70% vs 70-100%), and prior radiotherapy. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for a minimum of 8 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive gemcitabine IV over 30 minutes on day 1. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo 1 week of rest. Patients with stable or responding disease after week 8 may receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 4 weeks. Pain is assessed at within 7 days prior to study, at days 28 and 56 during study, and then every 28 days after completion of study. Patients are followed every 3 months for 1 year or until death. PROJECTED ACCRUAL: Approximately 994 patients (497 per arm) will be accrued for this study within 22 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 unresectable locally advanced (stage II or III) or metastatic (stage IV) adenocarcinoma of the pancreas --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior immunotherapy and recovered; No filgrastim (G-CSF) concurrent with nitrocamptothecin Concurrent epoetin alfa allowed - Chemotherapy: See Disease Characteristics - Prior fluorouracil as radiosensitizer allowed; No other prior chemotherapy (e.g., nitrocamptothecin or gemcitabine); No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal or corticosteroid therapy; Patients requiring hormonal therapy or corticosteroid therapy for medical reasons may remain on study, but will not be evaluable for clinical benefit response - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: More than 2 weeks since prior major surgery and recovered Prior stent placement allowed; No planned surgery within 8 weeks after initiation of treatment --Patient Characteristics-- - Age: Over 18 - Performance status: Karnofsky 50-100% - Life expectancy: Not specified - 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 normal (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
Dublin, California, 94568
United States
Additional Information:
Study ID Numbers: CDR0000067905; SUPERGEN-RFS2000-02
Study Start Date: November 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005869
Other Stage 4a Pancreatic Cancer Studies:
1. Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
2. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
3. DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
4. Gemcitabine With or Without Erlotinib 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
Related Studies:
Other stage 4A pancreatic cancer Clinical Trials
Other California Clinical Trials
Other Dublin Clinical Trials
Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
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