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Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer Clinical research trials and Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer. Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer  Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
For Condition: localized unresectable adult primary liver cancer,advanced adult primary liver cancer,recurrent adult primary liver cancer,adult primary hepatocellular carcinoma
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 1-2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenAlberts, Study Chair, Mayo Clinic Cancer Center
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Medcenter One Health System
Bismark, North Dakota, 58501-5505
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Additional Information:
Study ID Numbers: CDR0000068019; NCCTG-N0041
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006010
Other Advanced Adult Primary Liver Cancer Studies:
1. Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
2. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
3. DX-8951f in Treating Patients With Liver Cancer
4. Thalidomide Plus Interferon alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
5. Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
Related Studies:
Other advanced adult primary liver cancer Clinical Trials
Other Ohio Clinical Trials
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Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
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