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Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006010
First Posted: January 27, 2003
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
July 5, 2000
January 27, 2003
December 7, 2016
September 2001
May 2004   (Final data collection date for primary outcome measure)
six-month overall survival [ Time Frame: at 6 months ]
Not Provided
Complete list of historical versions of study NCT00006010 on ClinicalTrials.gov Archive Site
  • tumor response [ Time Frame: Up to 5 years ]
  • time to progression [ Time Frame: Up to 5 years ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Liver Cancer
  • Drug: docetaxel
  • Drug: gemcitabine hydrochloride
Experimental: 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.

Interventions:
  • Drug: docetaxel
  • Drug: gemcitabine hydrochloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2008
May 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00006010
NCCTG-N0041
NCI-2012-02349 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000068019 ( Registry Identifier: PDQ (Physician Data Query) )
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Steven R. Alberts, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP