- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00006010
Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel.
- Determine tumor response and time to progression in this patient population treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Assess the pharmacokinetics of docetaxel in patients treated with this regimen.
OUTLINE: Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342-1701
- CCOP - Atlanta Regional
-
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- MBCCOP - Hawaii
-
-
Illinois
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Peoria, Illinois, Förenta staterna, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Förenta staterna, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Förenta staterna, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Förenta staterna, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Förenta staterna, 51101-1733
- Siouxland Hematology-Oncology
-
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Kansas
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Wichita, Kansas, Förenta staterna, 67214-3882
- CCOP - Wichita
-
-
Minnesota
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Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501-5505
- Medcenter One Health System
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Ohio
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Toledo, Ohio, Förenta staterna, 43623-3456
- CCOP - Toledo Community Hospital
-
-
Pennsylvania
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Danville, Pennsylvania, Förenta staterna, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
-
-
South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57104
- CCOP - Sioux Community Cancer Consortium
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-
-
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable or metastatic hepatocellular carcinoma not amenable to combined radiotherapy and chemotherapy or orthotopic liver transplantation
- Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm
- Evidence of disease progression by serial imaging or biochemical evidence of a rising alpha-fetoprotein by serial testing
No history of brain or other CNS metastases not amenable to local therapy
- Locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery) allowed if no evidence of CNS progression for at least 4 weeks after completion of therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Other
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80
- No grade 2 or greater peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior biologic therapy or immunotherapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- Prior chemotherapy (excluding gemcitabine) for radiosensitization allowed
- At least 4 weeks since prior chemotherapy
- At least 6 months since prior chemoembolization
- No prior chemotherapy for metastatic disease
- No other concurrent chemotherapy
Endocrine therapy
- At least 4 weeks since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to 25% or more of bone marrow
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: docetaxel + gemcitabine
Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
six-month overall survival
Tidsram: at 6 months
|
at 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
tid till progression
Tidsram: Upp till 5 år
|
Upp till 5 år
|
tumor response
Tidsram: Up to 5 years
|
Up to 5 years
|
Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- Alberts SR, Reid JM, Morlan BW, Farr GH Jr, Camoriano JK, Johnson DB, Enger JR, Seay TE, Kim GP. Gemcitabine and docetaxel for hepatocellular carcinoma: a phase II North Central Cancer Treatment Group clinical trial. Am J Clin Oncol. 2012 Oct;35(5):418-23. doi: 10.1097/COC.0b013e318219863b.
- Kim GP, Alberts SR, Tschetter LK, et al.: Gemcitabine and docetaxel in patients with measurable unresectable or metastatic hepatocellular carcinoma (HCC), a North Central Cancer Treatment Group (NCCTG) phase II trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4270, 380s, 2004.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Gemcitabin
- Docetaxel
Andra studie-ID-nummer
- NCCTG-N0041
- NCI-2012-02349 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
- CDR0000068019 (Registeridentifierare: PDQ (Physician Data Query))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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