--- title: Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer nct_id: NCT00023972 overall_status: COMPLETED phase: PHASE3 sponsor: Daiichi Sankyo study_type: INTERVENTIONAL primary_condition: Pancreatic Cancer countries: United States, Canada, Puerto Rico canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00023972.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00023972" ct_last_update_post_date: 2012-05-16 last_seen_at: "2026-05-12T06:26:36.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer **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 **NCT ID:** [NCT00023972](https://clinicaltrials.gov/study/NCT00023972) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Lead Sponsor:** Daiichi Sankyo - **Conditions:** Pancreatic Cancer - **Start Date:** 2001-07 - **Completion Date:** 2005-04 - **CT.gov Last Update:** 2012-05-16 ## 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. ## Detailed 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Interventions - **exatecan mesylate** (DRUG) - **gemcitabine hydrochloride** (DRUG) ## Locations (74) - Intouch Research, Huntsville, Alabama, United States - Providence Cancer Center, Mobile, Alabama, United States - Arizona Clinical Research Center, Tucson, Arizona, United States - Medical Oncology/Hematology, Gilroy, California, United States - California Cancer Care, Inc., Greenbrae, California, United States - Pacific Shores Medical Group, Long Beach, California, United States - Cancer and Blood Institute of the Desert, Rancho Mirage, California, United States - Sutter Cancer Center, Sacramento, California, United States - University of Colorado Cancer Center, Denver, Colorado, United States - Medical Oncology and Hematology, P.C., Hamden, Connecticut, United States - nTouch Research, Melbourne, Florida, United States - Sylvester Cancer Center, University of Miami, Miami, Florida, United States - MD Anderson Cancer Center Orlando, Orlando, Florida, United States - H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States - Peachtree Hematology and Oncology Consultants, P.C., Atlanta, Georgia, United States - Emory University School of Medicine, Atlanta, Georgia, United States - Central Georgia Hematology Oncology, P.C., Macon, Georgia, United States - Cancer Research Center of Hawaii, Honolulu, Hawaii, United States - Northwestern Memorial Hospital, Chicago, Illinois, United States - Lutheran General Cancer Care Center, Park Ridge, Illinois, United States - Hope Center, Terre Haute, Indiana, United States - Harbor Hospital Center, Baltimore, Maryland, United States - Oncology-Hematology Associates, P.A., Clinton, Maryland, United States - Providence Hospital Cancer Center, Southfield, Michigan, United States - Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States - St. Joseph Oncology, Inc., Saint Joseph, Missouri, United States - St. Louis University Health Sciences Center, St Louis, Missouri, United States - Midwest Hematology Oncology Consultants, Ltd., St Louis, Missouri, United States - Billings Oncology Associates, Billings, Montana, United States - Great Falls Clinic, Great Falls, Montana, United States - Nevada Cancer Center, Las Vegas, Nevada, United States - Center for Cancer And Hematologic Disease, Cherry Hill, New Jersey, United States - Hematology Oncology Associates, Morristown, New Jersey, United States - Hematology and Oncology Group, Somerset, New Jersey, United States - Summit Medical Group, P.A., Summit, New Jersey, United States - HemOnCare, P.C., Brooklyn, New York, United States - Mary Imogene Bassett Hospital, Cooperstown, New York, United States - Nassau Hematology/Oncology PC, Lake Success, New York, United States - Memorial Sloan-Kettering Cancer Center, New York, New York, United States - State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States - New York Medical College, Valhalla, New York, United States - Buffalo Medical Group, P.C., Williamsville, New York, United States - Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States - Duke Comprehensive Cancer Center, Durham, North Carolina, United States - N.W. Carolina Oncology & Hematology, P.A., Hickory, North Carolina, United States - Ireland Cancer Center, Cleveland, Ohio, United States - Cleveland Clinic Cancer Center, Cleveland, Ohio, United States - Mid-Ohio Oncology/Hematology, Inc., Columbus, Ohio, United States - Medical Oncology Associates of Wyoming Valley, P.C., Kingston, Pennsylvania, United States - Lancaster Cancer Center, Lancaster, Pennsylvania, United States - University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States - Lifespan: The Miriam Hospital, Providence, Rhode Island, United States - Memorial Hospital Cancer Center - Chattanooga, Chattanooga, Tennessee, United States - Williamson Medical Center, Franklin, Tennessee, United States - Family Cancer Center, Germantown, Tennessee, United States - Jackson-Madison County General Hospital, Jackson, Tennessee, United States - Sarah Cannon-Minnie Pearl Cancer Center, Nashville, Tennessee, United States - Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States - Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States - Cancer Therapy and Research Center, San Antonio, Texas, United States - Scott and White Memorial Hospital, Temple, Texas, United States - Central Utah Medical Clinic, Provo, Utah, United States - Intermountain Hematology/Oncology Associates, Inc., Salt Lake City, Utah, United States - Rainier Oncology, Puyallup, Washington, United States - Yakima Regional Cancer Care Center, Yakima, Washington, United States - UW Cancer Center Wausau Hospital, Wausau, Wisconsin, United States - Cross Cancer Institute, Edmonton, Alberta, Canada - CancerCare Manitoba, Winnipeg, Manitoba, Canada - Northeastern Ontario Regional Cancer Centre, Sudbury, Greater Sudbury, Ontario, Canada - Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada - Queen Elizabeth Hospital, PEI, Charlottetown, Prince Edward Island, Canada - CHUM Hopital Saint-Luc, Montreal, Quebec, Canada - Montreal General Hospital, Montreal, Quebec, Canada - Veterans Affairs Medical Center - San Juan, San Juan, Puerto Rico ## Recent Field Changes (last 30 days) - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.intouch research|huntsville|alabama|united states` — added _(2026-05-12)_ - `locations.providence cancer center|mobile|alabama|united states` — added _(2026-05-12)_ - `locations.arizona clinical research center|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.medical oncology/hematology|gilroy|california|united states` — added _(2026-05-12)_ - `locations.california cancer care, inc.|greenbrae|california|united states` — added _(2026-05-12)_ - `locations.pacific shores medical group|long beach|california|united states` — added _(2026-05-12)_ - `locations.cancer and blood institute of the desert|rancho mirage|california|united states` — added _(2026-05-12)_ - `locations.sutter cancer center|sacramento|california|united states` — added _(2026-05-12)_ - `locations.university of colorado cancer center|denver|colorado|united states` — added _(2026-05-12)_ - `locations.medical oncology and hematology, p.c.|hamden|connecticut|united states` — added _(2026-05-12)_ - `locations.ntouch research|melbourne|florida|united states` — added _(2026-05-12)_ - `locations.sylvester cancer center, university of miami|miami|florida|united states` — added _(2026-05-12)_ - `locations.md anderson cancer center orlando|orlando|florida|united states` — added _(2026-05-12)_ - `locations.h. lee moffitt cancer center and research institute|tampa|florida|united states` — added _(2026-05-12)_ - `locations.peachtree hematology and oncology consultants, p.c.|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.emory university school of medicine|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.central georgia hematology oncology, p.c.|macon|georgia|united states` — added _(2026-05-12)_ - `locations.cancer research center of hawaii|honolulu|hawaii|united states` — added _(2026-05-12)_ - `locations.northwestern memorial hospital|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.lutheran general cancer care center|park ridge|illinois|united states` — added _(2026-05-12)_ - `locations.hope center|terre haute|indiana|united states` — added _(2026-05-12)_ - `locations.harbor hospital center|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.oncology-hematology associates, p.a.|clinton|maryland|united states` — added _(2026-05-12)_ - `locations.providence hospital cancer center|southfield|michigan|united states` — added _(2026-05-12)_ - `locations.virginia piper cancer institute|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.st. joseph oncology, inc.|saint joseph|missouri|united states` — added _(2026-05-12)_ - `locations.st. louis university health sciences center|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.midwest hematology oncology consultants, ltd.|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.billings oncology associates|billings|montana|united states` — added _(2026-05-12)_ - `locations.great falls clinic|great falls|montana|united states` — added _(2026-05-12)_ - `locations.nevada cancer center|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.center for cancer and hematologic disease|cherry hill|new jersey|united states` — added _(2026-05-12)_ - `locations.hematology oncology associates|morristown|new jersey|united states` — added _(2026-05-12)_ - `locations.hematology and oncology group|somerset|new jersey|united states` — added _(2026-05-12)_ - `locations.summit medical group, p.a.|summit|new jersey|united states` — added _(2026-05-12)_ - `locations.hemoncare, p.c.|brooklyn|new york|united states` — added _(2026-05-12)_ - `locations.mary imogene bassett hospital|cooperstown|new york|united states` — added _(2026-05-12)_ - `locations.nassau hematology/oncology pc|lake success|new york|united states` — added _(2026-05-12)_ - `locations.memorial sloan-kettering cancer center|new york|new york|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00023972.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00023972* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*