Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer
NCT ID: NCT00004861
Last Updated: 2012-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-10-31
2001-09-30
Brief Summary
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PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced pancreatic cancer.
Detailed Description
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OUTLINE: Gemcitabine is the standard of care for pancreatic cancer and is administered by intravenous injection. Patients receive gemcitabine once a week for 3 weeks followed by 1 week of rest. Patients take the capsules (placebo or investigational chemotherapy) daily for 21 consecutive days beginning with the first gemcitabine infusion. The duration of treatment is determined by the patient's tolerance of therapy and the assessment of disease response.
PROJECTED ACCRUAL: A total of 172 patients will be enrolled in Canada, Europe, and the United States on a competitive basis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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gemcitabine hydrochloride
tacedinaline
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Age greater than or equal to 18 years Performance status: Karnofsky 70-100% Life expectancy: Expected survival greater than 12 weeks Hematopoietic: No inadequate bone marrow function within 2 weeks prior to randomization as evidenced by the following: Absolute neutrophil count less than 2000/mm3 Platelet count less than 100,000/mm3 Hepatic: No inadequate hepatic function within 2 weeks prior to randomization as evidenced by the following: Total bilirubin greater than 1.5 times upper limit of normal (ULN) AST or ALT greater than 3 times ULN (greater than 5 times ULN if liver metastases is documented) Renal: No inadequate renal function within 2 weeks prior to randomization as evidenced by the following: Creatinine clearance less than 50 mL/min Other: Adequate IV access to receive gemcitabine infusion Capable of swallowing intact study medication capsules Capable of giving informed consent Capable of following instructions or having a daily caregiver who assumes responsibility for administering study medication and completing medication diaries No life threatening illness (unrelated to tumor) No women of childbearing potential unless using an acceptable method of contraception, or who are pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy or biologic therapy may be allowed, but must have been completed at least 1 month prior to randomization Chemotherapy: No prior chemotherapy for advanced stage pancreatic cancer Fluorouracil (with or without leucovorin calcium or interferon) given with radiation as a radiation sensitizer may be allowed, but must have been completed at least 3 months prior to randomization Endocrine therapy: Prior hormonal therapy may be allowed, but must have been completed at least 1 month prior to randomization Radiotherapy: No radiation therapy within 4 weeks prior to first treatment Surgery: See Disease Characteristics
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Kathy M. Diener, PharmD
Role: STUDY_CHAIR
Pfizer Incorporated - Ann Arbor
Locations
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Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
West Clinic, P.C.
Memphis, Tennessee, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States
Tyler Cancer Center
Tyler, Texas, United States
Northern Virginia Oncology Group
Fairfax, Virginia, United States
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CDR0000067513
Identifier Type: -
Identifier Source: secondary_id
ILEX-994-011
Identifier Type: -
Identifier Source: secondary_id
PD-994-011
Identifier Type: -
Identifier Source: org_study_id