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Jacksonville, Florida 32224

  • Liver Cancer

Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

NCCTG-N0041


NCT ID:

NCT00006010


Secondary ID:

NCI-2012-02349


Study Acronym:


Brief Title:

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


Official Title:

Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven R. Alberts, MD
Study Chair
Mayo Clinic

Study Dates

Start Date:September 2001
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:May 2004
Primary Completion Type:Actual
Verification Date:December 2016
Last Changed Date:December 5, 2016
First Received Date:July 5, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:six-month overall survival
Time Frame:at 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:tumor response
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:time to progression
Time Frame:Up to 5 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:docetaxel
Arm Name:docetaxel + gemcitabine
Intervention Type:Drug
Name:gemcitabine hydrochloride
Arm Name:docetaxel + gemcitabine

Study Arms

Study Arm Type:Experimental
Arm Name:docetaxel + gemcitabine
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:21555932
Reference Type:Results Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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