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Home > "G" Clinical Trials Conditions > Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer  Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
For Condition: Pancreatic Cancer,Quality of Life,Thromboembolism,adenocarcinoma of the pancreas
Status: Recruiting
Sponsor(s): University of Rochester , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastaticpancreatic cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.
Details: OBJECTIVES: - Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin. - Compare the survival of patients treated with these regimens. - Compare the incidence of venous thromboembolic complications in patients treated with these regimens. - Determine the safety of dalteparin, in terms of bleeding complications, in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression. - Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity. Quality of life is assessed at baseline and every 4 weeks during study therapy. Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,500/mm^3 - Platelet count greater than 100,000/mm^3 - No clinically significant bleeding disorder - No prior heparin-induced thrombocytopenia Hepatic: - Bilirubin less than 2.0 mg/dL - AST less than 3 times normal Renal: - Creatinine less than 2.0 mg/dL Cardiovascular: - No prior hemorrhagic stroke - No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other active malignancy - No gastrointestinal bleeding within the past 30 days - No contraindications to anticoagulation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for metastatic disease - Prior adjuvant chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Prior surgical resection allowed - At least 4 weeks since prior surgery with non-curative intent and recovered - More than 30 days since prior neurologic or ophthalmologic surgery Other: - At least 2 weeks since prior low-molecular-weight heparin - More than 30 days since prior experimental therapeutic agent - No concurrent heparin or warfarin for pre-existing condition
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KishanPandya, Study Chair, University of Rochester
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
University of Rochester Cancer Center CCOP Research Base *Recruiting*
Rochester, New York, 14642
United States
Recruiting Alok Khorana 585-275-5345
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-435-3941
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1677
Additional Information:
Study ID Numbers: CDR0000069232; NCI-5012,NCI-CCC-99-45,NCI-P02-0212,URCC-2200
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031837
Other Quality Of Life Studies:
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2. Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Stage III or Stage IV Head and Neck Cancer
3. Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
4. Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer
5. Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
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Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
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