Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004861
• Other study ID #: PD-994-011
• Secondary ID: CDR0000067513ILE
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: August 8, 2012
• Start date: October 1999
• Est. completion date: September 2001

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• tacedinaline

Locations

Country	Name	City	State
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Jewish Hospital of Cincinnati, Inc.	Cincinnati	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Northern Virginia Oncology Group	Fairfax	Virginia
United States	Cedars-Sinai Comprehensive Cancer Center	Los Angeles	California
United States	West Clinic, P.C.	Memphis	Tennessee
United States	Sarah Cannon-Minnie Pearl Cancer Center	Nashville	Tennessee
United States	Raleigh Hematology/Oncology Associates - Wake Practice	Raleigh	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,