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Sponsored by: |
Pfizer Incorporated - Ann Arbor |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004861 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: acetyldinaline Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion in the Treatment of Patients With Advanced Pancreatic Cancer |
Study Start Date: | October 1999 |
OBJECTIVES: I. Determine the efficacy and safety of CI-994 given in combination with gemcitabine compared to gemcitabine alone in the treatment of patients with advanced pancreatic cancer.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologic or cytologic diagnosis of advanced (stage II or III) or metastatic (stage IV) adenocarcinoma of the exocrine pancreas and not considered a surgical candidate Measurable or unmeasurable disease
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
United States, California | |
Cedars-Sinai Comprehensive Cancer Center | |
Los Angeles, California, United States, 90048 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 | |
United States, Maryland | |
Sinai Hospital of Baltimore | |
Baltimore, Maryland, United States, 21225 | |
United States, Michigan | |
William Beaumont Hospital | |
Royal Oak, Michigan, United States, 48073 | |
United States, North Carolina | |
Raleigh Hematology/Oncology Associates - Wake Practice | |
Raleigh, North Carolina, United States, 27609 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Jewish Hospital of Cincinnati, Inc. | |
Cincinnati, Ohio, United States, 45236 | |
United States, Tennessee | |
Sarah Cannon-Minnie Pearl Cancer Center | |
Nashville, Tennessee, United States, 37203 | |
West Clinic, P.C. | |
Memphis, Tennessee, United States, 38117 | |
United States, Texas | |
Tyler Cancer Center | |
Tyler, Texas, United States, 75702 | |
United States, Virginia | |
Northern Virginia Oncology Group | |
Fairfax, Virginia, United States, 22031 | |
Canada, Manitoba | |
St. Boniface General Hospital | |
Winnipeg, Manitoba, Canada, R2H 2A6 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Ottawa Regional Cancer Center - General Division | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Canada, Quebec | |
Centre Hospitalier de l'Universite de Montreal | |
Montreal, Quebec, Canada, H2L-4M1 |
Study Chair: | Kathy M. Diener, PharmD | Pfizer Incorporated - Ann Arbor |
Study ID Numbers: | CDR0000067513, PD-994-011, ILEX-994-011 |
Study First Received: | March 7, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004861 History of Changes |
Health Authority: | United States: Federal Government |
stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents Pancrelipase Antiviral Agents |
Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |