ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00003316CDR0000066265GOG-131ENCT00003316Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the UterusEvaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the UterusGynecologic Oncology GroupOtherNational Cancer Institute (NCI)NIH
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with
recurrent or refractory cancer of the uterus.
OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or
persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II.
Determine the toxicity of gemcitabine in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat
every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with
partial response, complete response, or stable disease receive at least 3 courses of therapy.
Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
TerminatedAugust 1998April 2004Phase 2InterventionalNoTreatmentSarcomaDruggemcitabine hydrochloride
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine
leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local
therapeutic measures and considered incurable Measurable disease Not eligible for a higher
priority GOG protocol
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal
Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5
years since any other invasive malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine
No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine
therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks
since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and
recovered
Female18 YearsN/ANoKatherine Y. Look, MDStudy ChairIndiana University Melvin and Bren Simon Cancer CenterUniversity of Alabama Comprehensive Cancer CenterBirminghamAlabama35294United StatesCCOP - Greater PhoenixPhoenixArizona85006-2726United StatesJonsson Comprehensive Cancer Center, UCLALos AngelesCalifornia90095-1781United StatesChao Family Comprehensive Cancer CenterOrangeCalifornia92868United StatesWalter Reed Army Medical CenterWashingtonDistrict of Columbia20307-5000United StatesH. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612United StatesRush-Presbyterian-St. Luke's Medical CenterChicagoIllinois60612United StatesUniversity of Chicago Cancer Research CenterChicagoIllinois60637United StatesIndiana University Cancer CenterIndianapolisIndiana46202-5265United StatesUniversity of Iowa Hospitals and ClinicsIowa CityIowa52242United StatesRadiation Oncology BranchBethesdaMaryland20892United StatesTufts University School of MedicineBostonMassachusetts02111United StatesUniversity of Massachusetts Memorial Medical CenterWorcesterMassachusetts01655United StatesBarbara Ann Karmanos Cancer InstituteDetroitMichigan48201United StatesUniversity of Minnesota Cancer CenterMinneapolisMinnesota55455United StatesUniversity of Mississippi Medical CenterJacksonMississippi39216-4505United StatesCCOP - Kansas CityKansas CityMissouri64131United StatesWashington University School of MedicineSaint LouisMissouri63110United StatesCCOP - Southern Nevada Cancer Research FoundationLas VegasNevada89106United StatesCooper Hospital/University Medical CenterCamdenNew Jersey08103United StatesCancer Center of Albany Medical CenterAlbanyNew York12208United StatesState University of New York Health Science Center at BrooklynBrooklynNew York11203United StatesLineberger Comprehensive Cancer Center, UNCChapel HillNorth Carolina27599-7295United StatesDuke Comprehensive Cancer CenterDurhamNorth Carolina27710United StatesComprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-SalemNorth Carolina27157-1082United StatesBarrett Cancer Center, The University HospitalCincinnatiOhio45219United StatesIreland Cancer CenterClevelandOhio44106-5065United StatesCleveland Clinic Taussig Cancer CenterClevelandOhio44195United StatesArthur G. James Cancer Hospital - Ohio State UniversityColumbusOhio43210United StatesUniversity of Oklahoma College of MedicineOklahoma CityOklahoma73190United StatesAbington Memorial HospitalAbingtonPennsylvania19001United StatesMilton S. Hershey Medical CenterHersheyPennsylvania17033United StatesUniversity of Pennsylvania Cancer CenterPhiladelphiaPennsylvania19104United StatesKimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphiaPennsylvania19107United StatesFox Chase Cancer CenterPhiladelphiaPennsylvania19111United StatesCCOP - Upstate CarolinaSpartanburgSouth Carolina29303United StatesSimmons Cancer Center - DallasDallasTexas75235-9154United StatesUniversity of Washington Medical CenterSeattleWashington98195-6043United StatesTacoma General HospitalTacomaWashington98405United StatesNCIC-Clinical Trials GroupKingstonOntarioK7L 3N6CanadaCanadaUnited StatesLook KY, Sandler A, Blessing JA, Lucci JA 3rd, Rose PG; Gynecologic Oncology Group (GOG) Study. Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) Study. Gynecol Oncol. 2004 Feb;92(2):644-7. doi: 10.1016/j.ygyno.2003.11.023.14766260May 2004November 6, 2000April 8, 2004April 9, 2004April 10, 2013April 10, 2013April 11, 2013recurrent uterine sarcomauterine leiomyosarcomaSarcomaGemcitabine