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3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer Clinical research trials and 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "3" Clinical Trials Conditions > 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer  3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
For Condition: stage 4B pancreatic cancer,recurrent pancreatic cancer,stage 4A pancreatic cancer,stage 3 pancreatic cancer,stage 2 pancreatic cancer
Status: Recruiting
Sponsor(s): Vion Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have unresectable or metastaticpancreatic cancer.
Details: OBJECTIVES: - Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine. - Determine the progression-free interval and survival of patients treated with this regimen. - Determine the safety and feasibility of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed pancreatic cancer - Unresectable or metastatic disease - Measurable disease - Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and ALT less than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases) - Chronic viral hepatitis allowed Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - No myocardial infarction within the past 3 months - No uncontrolled congestive heart failure - No uncontrolled coronary artery disease - No uncontrolled arrhythmias Pulmonary - No dyspnea at rest - No dependence on supplemental oxygen Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No other malignancy except any of the following: - Carcinoma in situ of the cervix treated with cone biopsy or resection - Nonmetastatic basal cell or squamous cell skin cancer - Any stage I malignancy curatively resected more than 5 years ago - No active infection - No other concurrent life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy - Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed Chemotherapy - No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - More than 3 weeks since prior surgery and recovered Other - More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Paul Ross 44-20-8642-6011
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Marc Peeters 32-9-240-2111
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Juan Valle 44-161-446-3000
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Hedy Kindler 773-702-0360
Maasland Hospital *Recruiting*
Sittard, , 6131 BK
Netherlands
Recruiting F.L.G. Erdkamp 31-46-459-7777
Sarah Cannon Cancer Center at Centennial Medical Center *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Howard Burris 615-986-4300
Indiana Oncology Hematology Consultants *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Robert Nelson 317-927-5770
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Edward Greeno 612-626-2569
Additional Information:
Study ID Numbers: CDR0000306461; VION-CLI-031
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064051
Other Stage 2 Pancreatic Cancer Studies:
1. Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
2. UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
3. Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
4. Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
5. Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer
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Other stage 2 pancreatic cancer Clinical Trials
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3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
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