Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023972
• Other study ID #: CDR0000068880
• Secondary ID: DAIICHI-8951A-PR
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2001
• Last updated: May 15, 2012
• Start date: July 2001
• Est. completion date: April 2005

Study information

• Verified date: May 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• 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. It is not yet known if gemcitabine is more effective with or without exatecan mesylate in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.

Description:

OBJECTIVES:

• Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone.

• Compare the measures of clinical benefit in patients treated with these regimens.

• Compare the anti-tumor efficacy of these regimens in this patient population.

• Determine the safety profile of exatecan mesylate and gemcitabine in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (60% vs 70-80% vs 90-100%), extent of disease (locally advanced vs metastatic), and prior radiotherapy for pancreatic cancer (yes or no). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest (course 1). For all subsequent courses, patients receive gemcitabine once weekly for 3 weeks followed by one week of rest. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly.

PROJECTED ACCRUAL: Approximately 340 patients (170 per treatment arm) will be accrued for this study within 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas

• Locally advanced (unresectable) or metastatic disease

• No islet cell tumor, lymphoma, or sarcoma of the pancreas

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST no greater than 5 times ULN

• Albumin at least 2.8 g/dL

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No active congestive heart failure

• No uncontrolled angina

• No myocardial infarction

Other:

• No serious infection or life-threatening illness unrelated to tumor

• No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No overt psychosis or incompetency that would preclude study

• No history of a positive serology for HIV

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior systemic anticancer immunotherapy for pancreatic cancer

• No concurrent anticancer immunotherapy or other biologic therapy

Chemotherapy:

• No prior systemic anticancer chemotherapy for pancreatic cancer

• Prior fluorouracil as a radiosensitizer allowed

• No prior gemcitabine as a radiosensitizer

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• Concurrent megestrol for appetite stimulation allowed

Radiotherapy:

• At least 28 days since prior radiotherapy and recovered

• No prior radiotherapy to more than 25% of estimated bone marrow reserve

• No concurrent anticancer radiotherapy

Surgery:

• At least 28 days since prior major surgery and recovered

• No concurrent surgery for cancer

Other:

• No prior investigational or other systemic anticancer therapy for pancreatic cancer

• No other concurrent investigational drugs

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• exatecan mesylate

• gemcitabine hydrochloride

Locations

Country	Name	City	State
Canada	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUM Hopital Saint-Luc	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Puerto Rico	Veterans Affairs Medical Center - San Juan	San Juan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Peachtree Hematology and Oncology Consultants, P.C.	Atlanta	Georgia
United States	Harbor Hospital Center	Baltimore	Maryland
United States	Billings Oncology Associates	Billings	Montana
United States	HemOnCare, P.C.	Brooklyn	New York
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Memorial Hospital Cancer Center - Chattanooga	Chattanooga	Tennessee
United States	Center for Cancer And Hematologic Disease	Cherry Hill	New Jersey
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Oncology-Hematology Associates, P.A.	Clinton	Maryland
United States	Mid-Ohio Oncology/Hematology, Inc.	Columbus	Ohio
United States	Mary Imogene Bassett Hospital	Cooperstown	New York
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Williamson Medical Center	Franklin	Tennessee
United States	Family Cancer Center	Germantown	Tennessee
United States	Medical Oncology/Hematology	Gilroy	California
United States	Great Falls Clinic	Great Falls	Montana
United States	California Cancer Care, Inc.	Greenbrae	California
United States	Medical Oncology and Hematology, P.C.	Hamden	Connecticut
United States	N.W. Carolina Oncology & Hematology, P.A.	Hickory	North Carolina
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Intouch Research	Huntsville	Alabama
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Medical Oncology Associates of Wyoming Valley, P.C.	Kingston	Pennsylvania
United States	Nassau Hematology/Oncology PC	Lake Success	New York
United States	Lancaster Cancer Center	Lancaster	Pennsylvania
United States	Nevada Cancer Center	Las Vegas	Nevada
United States	Pacific Shores Medical Group	Long Beach	California
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Central Georgia Hematology Oncology, P.C.	Macon	Georgia
United States	nTouch Research	Melbourne	Florida
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Providence Cancer Center	Mobile	Alabama
United States	Hematology Oncology Associates	Morristown	New Jersey
United States	Sarah Cannon-Minnie Pearl Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	MD Anderson Cancer Center Orlando	Orlando	Florida
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Lifespan: The Miriam Hospital	Providence	Rhode Island
United States	Central Utah Medical Clinic	Provo	Utah
United States	Rainier Oncology	Puyallup	Washington
United States	Cancer and Blood Institute of the Desert	Rancho Mirage	California
United States	Sutter Cancer Center	Sacramento	California
United States	St. Joseph Oncology, Inc.	Saint Joseph	Missouri
United States	Midwest Hematology Oncology Consultants, Ltd.	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Intermountain Hematology/Oncology Associates, Inc.	Salt Lake City	Utah
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	Hematology and Oncology Group	Somerset	New Jersey
United States	Providence Hospital Cancer Center	Southfield	Michigan
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Summit Medical Group, P.A.	Summit	New Jersey
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Hope Center	Terre Haute	Indiana
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	New York Medical College	Valhalla	New York
United States	UW Cancer Center Wausau Hospital	Wausau	Wisconsin
United States	Buffalo Medical Group, P.C.	Williamsville	New York
United States	Yakima Regional Cancer Care Center	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (1)

Abou-Alfa GK, Letourneau R, Harker G, Modiano M, Hurwitz H, Tchekmedyian NS, Feit K, Ackerman J, De Jager RL, Eckhardt SG, O'Reilly EM. Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic — View Citation