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

NCT00023972 | Completed Phase 3

• 3 other identifiers: CDR0000068880DAIICHI-8951A-PRT031MSKCC-02011
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 74

Brief 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.

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer; stage IV pancreatic cancer

Interventions

exatecan mesylate DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (74)

Intouch Research

Huntsville, Alabama, 35801, United States

Location

Providence Cancer Center

Mobile, Alabama, 36608, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Medical Oncology/Hematology

Gilroy, California, 95020, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904-2007, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Medical Oncology and Hematology, P.C.

Hamden, Connecticut, 06518, United States

Location

nTouch Research

Melbourne, Florida, 32901, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Peachtree Hematology and Oncology Consultants, P.C.

Atlanta, Georgia, 30309, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Central Georgia Hematology Oncology, P.C.

Macon, Georgia, 31201, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813-2424, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611-5933, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Hope Center

Terre Haute, Indiana, 47802, United States

Location

Harbor Hospital Center

Baltimore, Maryland, 21215-1290, United States

Location

Oncology-Hematology Associates, P.A.

Clinton, Maryland, 20735, United States

Location

Providence Hospital Cancer Center

Southfield, Michigan, 48075, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Midwest Hematology Oncology Consultants, Ltd.

St Louis, Missouri, 63136, United States

Location

Billings Oncology Associates

Billings, Montana, 59101, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Nevada Cancer Center

Las Vegas, Nevada, 89109, United States

Location

Center for Cancer And Hematologic Disease

Cherry Hill, New Jersey, 08046, United States

Location

Hematology Oncology Associates

Morristown, New Jersey, 07962, United States

Location

Hematology and Oncology Group

Somerset, New Jersey, 08873, United States

Location

Summit Medical Group, P.A.

Summit, New Jersey, 07901, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

Nassau Hematology/Oncology PC

Lake Success, New York, 11042, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11794-8174, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Buffalo Medical Group, P.C.

Williamsville, New York, 14221, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

N.W. Carolina Oncology & Hematology, P.A.

Hickory, North Carolina, 28602, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-1714, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44111, United States

Location

Mid-Ohio Oncology/Hematology, Inc.

Columbus, Ohio, 43222, United States

Location

Medical Oncology Associates of Wyoming Valley, P.C.

Kingston, Pennsylvania, 18704-5527, United States

Location

Lancaster Cancer Center

Lancaster, Pennsylvania, 17604, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Memorial Hospital Cancer Center - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Williamson Medical Center

Franklin, Tennessee, 37067, United States

Location

Family Cancer Center

Germantown, Tennessee, 38138, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Sarah Cannon-Minnie Pearl Cancer Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6307, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229-3271, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76502, United States

Location

Central Utah Medical Clinic

Provo, Utah, 84604, United States

Location

Intermountain Hematology/Oncology Associates, Inc.

Salt Lake City, Utah, 84124-1363, United States

Location

Rainier Oncology

Puyallup, Washington, 98372, United States

Location

Yakima Regional Cancer Care Center

Yakima, Washington, 98902, United States

Location

UW Cancer Center Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Queen Elizabeth Hospital, PEI

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

CHUM Hopital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Veterans Affairs Medical Center - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Related 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 cancer. J Clin Oncol. 2006 Sep 20;24(27):4441-7. doi: 10.1200/JCO.2006.07.0201.

  PMID: 16983112 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

exatecan; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Robert L. DeJager, MD, FACP

  Daiichi Sankyo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

CA (7); US (66); PR (1)