Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
NCT ID: NCT00006010
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2001-09-30
2008-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
docetaxel
gemcitabine hydrochloride
Interventions
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docetaxel
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Steven R. Alberts, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Medcenter One Health System
Bismarck, North Dakota, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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References
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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.
Other Identifiers
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NCI-2012-02349
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000068019
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N0041
Identifier Type: -
Identifier Source: org_study_id