Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Kathy M. Diener, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

Pfizer Incorporated - Ann Arbor

Authority:

United States: Federal Government

Study ID:

PD-994-011

NCT ID:

NCT00004861

Start Date:

October 1999

Completion Date:

September 2001

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Ireland Cancer CenterCleveland, Ohio  44106-5065
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Sarah Cannon-Minnie Pearl Cancer CenterNashville, Tennessee  37203
Jewish Hospital of Cincinnati, Inc.Cincinnati, Ohio  45236
William Beaumont HospitalRoyal Oak, Michigan  48073
West Clinic, P.C.Memphis, Tennessee  38117
Cedars-Sinai Comprehensive Cancer CenterLos Angeles, California  90048
Raleigh Hematology/Oncology Associates - Wake PracticeRaleigh, North Carolina  27609
Tyler Cancer CenterTyler, Texas  75702
Northern Virginia Oncology GroupFairfax, Virginia  22031