Clinical trial NCT00004861: Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-06-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Comprehensive Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Raleigh
country: United States
facility: Raleigh Hematology/Oncology Associates - Wake Practice
state: North Carolina
city: Cincinnati
country: United States
facility: Jewish Hospital of Cincinnati, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Memphis
country: United States
facility: West Clinic, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon-Minnie Pearl Cancer Center
state: Tennessee
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Northern Virginia Oncology Group
state: Virginia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Center - General Division
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
Study officials:
affiliation: Pfizer Incorporated - Ann Arbor
name: Kathy M. Diener, PharmD
role: STUDY_CHAIR
References: