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Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas

12 luglio 2016 aggiornato da: Alliance for Clinical Trials in Oncology

A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer

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 when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas.

PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

  • Compare the overall survival rate of patients with metastatic pancreatic cancer treated with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.
  • Compare the time to disease progression in patients treated with these regimens.
  • Compare the CA 19-9 biomarker response in patients treated with these regimens.
  • Correlate the CA 19-9 biomarker response with survival in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the response in patients with measurable disease treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
  • Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study within 30 months.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

259

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • San Juan, Porto Rico, 00936-5067
        • University of Puerto Rico School of Medicine Medical Sciences Campus
  • Stati Uniti
    • Alabama
      • Anniston, Alabama, Stati Uniti, 36207
        • Northeast Alabama Regional Medical Center
    • California
      • La Jolla, California, Stati Uniti, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • San Diego, California, Stati Uniti, 92161
        • Veterans Affairs Medical Center - San Diego
      • San Francisco, California, Stati Uniti, 94115
        • UCSF Comprehensive Cancer Center
      • San Francisco, California, Stati Uniti, 94121
        • Veterans Affairs Medical Center - San Francisco
    • Delaware
      • Newark, Delaware, Stati Uniti, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, Stati Uniti, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, Stati Uniti, 20007
        • Lombardi Cancer Center
    • Florida
      • Fort Lauderdale, Florida, Stati Uniti, 33316
        • Broward General Medical Center
      • Hollywood, Florida, Stati Uniti, 33021
        • Memorial Regional Hospital Comprehensive Cancer Center
      • Miami Beach, Florida, Stati Uniti, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, Stati Uniti, 32804
        • Florida Hospital Cancer Institute
      • West Palm Beach, Florida, Stati Uniti, 33401
        • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, Stati Uniti, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Stati Uniti, 60640
        • Louis A. Weiss Memorial Hospital
      • River Forest, Illinois, Stati Uniti, 60305
        • West Suburban Center for Cancer Care
      • Rockford, Illinois, Stati Uniti, 61108
        • Saint Anthony Medical Center
    • Indiana
      • Fort Wayne, Indiana, Stati Uniti, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Incorporated
      • South Bend, Indiana, Stati Uniti, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Bettendorf, Iowa, Stati Uniti, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Iowa City, Iowa, Stati Uniti, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40207
        • Baptist Hospital East - Louisville
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Veterans Affairs Medical Center - Baltimore
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Worcester, Massachusetts, Stati Uniti, 01655
        • University of Massachusetts Memorial Medical Center - University Campus
    • Michigan
      • Saint Joseph, Michigan, Stati Uniti, 49085
        • Lakeland Medical Center - St. Joseph
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65201
        • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      • Columbia, Missouri, Stati Uniti, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198-7680
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Veterans Affairs Medical Center - Las Vegas
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756-0002
        • Norris Cotton Cancer Center
    • New Jersey
      • Camden, New Jersey, Stati Uniti, 08103
        • Cooper University Hospital
    • New York
      • Buffalo, New York, Stati Uniti, 14263-0001
        • Roswell Park Cancer Institute
      • Buffalo, New York, Stati Uniti, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Elmhurst, New York, Stati Uniti, 11373
        • Elmhurst Hospital Center
      • Jamaica, New York, Stati Uniti, 11432
        • Queens Cancer Center of Queens Hospital
      • Manhasset, New York, Stati Uniti, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Stati Uniti, 11030
        • North Shore University Hospital
      • New York, New York, Stati Uniti, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Stati Uniti, 10029
        • Mount Sinai Medical Center, NY
      • New York, New York, Stati Uniti, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • Syracuse, New York, Stati Uniti, 13210
        • State University of New York - Upstate Medical University
      • Syracuse, New York, Stati Uniti, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, Stati Uniti, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28805
        • Veterans Affairs Medical Center - Asheville
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Concord, North Carolina, Stati Uniti, 28025
        • NorthEast Oncology Associates
      • Durham, North Carolina, Stati Uniti, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke Comprehensive Cancer Center
      • Fayetteville, North Carolina, Stati Uniti, 28302-2000
        • Cape Fear Valley Health System
      • Kinston, North Carolina, Stati Uniti, 28503-1678
        • Lenoir Memorial Hospital Cancer Center
      • Pinehurst, North Carolina, Stati Uniti, 28374
        • FirstHealth Moore Regional Hospital
      • Wilmington, North Carolina, Stati Uniti, 28402-9025
        • New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, Stati Uniti, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, Stati Uniti, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, Stati Uniti, 58102
        • Veterans Affairs Medical Center - Fargo
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02906
        • Lifespan: The Miriam Hospital
    • Texas
      • Dallas, Texas, Stati Uniti, 75216
        • Veterans Affairs Medical Center - Dallas
    • Vermont
      • Bennington, Vermont, Stati Uniti, 05201
        • Green Mountain Oncology Group
      • Burlington, Vermont, Stati Uniti, 05401-3498
        • Vermont Cancer Center at University of Vermont
      • White River Junction, Vermont, Stati Uniti, 05009
        • Veterans Affairs Medical Center - White River Junction
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22902
        • Martha Jefferson Hospital
      • Norfolk, Virginia, Stati Uniti, 23502
        • Virginia Oncology Associates - Norfolk
      • Richmond, Virginia, Stati Uniti, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Roanoke, Virginia, Stati Uniti, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • West Virginia
      • Huntington, West Virginia, Stati Uniti, 25701
        • St. Mary's Medical Center
    • Wisconsin
      • Rhinelander, Wisconsin, Stati Uniti, 54501
        • Ministry Medical Group - Northern Region

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the pancreas
  • Metastatic disease by CT scan

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN
  • Alkaline phosphatase any value if SGOT less than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study
  • No other currently active malignancy (completed therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy:

  • No prior chemotherapy except fluorouracil (5-FU)
  • At least 2 weeks since prior 5-FU
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy for non-disease related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic

Radiotherapy:

  • At least 2 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Gemcitabine
Standard treatment
Droga: gemcitabine hydrochloride

Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, & 15 of ea cycle

  • cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle
  • docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 & 8 of ea cycle
Sperimentale: Gemcitabine + cisplastin
Addition of cisplastin to gemcitabine
Droga: gemcitabine hydrochloride

Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, & 15 of ea cycle

  • cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle
  • docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 & 8 of ea cycle
Droga: cisplatin
50 mg/sq m IV infusion over 30 min on Days 1 & 15 of ea cycle
Sperimentale: Gemcitabine + docetaxel
Addition of docetaxel to gemcitabine
Droga: gemcitabine hydrochloride

Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, & 15 of ea cycle

  • cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle
  • docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 & 8 of ea cycle
Droga: docetaxel
40 mg/sq m IV infusion over 60 min on Days 1 & 8 of ea treatment cycle
Sperimentale: Gemcitabine + Irinotecan
Addition of irinotecan to gemcitabine
Droga: gemcitabine hydrochloride

Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, & 15 of ea cycle

  • cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle
  • docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 & 8 of ea cycle
Droga: irinotecan hydrochloride
100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 & 8 of ea cycle

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Overall Survival
Lasso di tempo: 4 years post treatment
4 years post treatment

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Time to disease progression
Lasso di tempo: treatment up to 4 years post treatment
treatment up to 4 years post treatment
Toxicity
Lasso di tempo: treatment and up to 4 years post treatment
treatment and up to 4 years post treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Matthew Kulke, MD, Dana-Farber Cancer Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2001

Completamento primario (Effettivo)

1 giugno 2004

Completamento dello studio (Effettivo)

1 aprile 2009

Date di iscrizione allo studio

Primo inviato

3 marzo 2001

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 luglio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 luglio 2016

Ultimo verificato

1 luglio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CALGB-89904
  • U10CA031946 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CDR0000068495 (Identificatore di registro: NCI Physician Data Query)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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