Clinical trial NCT00006010: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Keywords: localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: six-month overall survival
timeFrame: at 6 months
Secondary outcomes:
measure: tumor response
timeFrame: Up to 5 years
measure: time to progression
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Scottsdale Oncology Program
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Atlanta
country: United States
facility: CCOP - Atlanta Regional
state: Georgia
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Bismarck
country: United States
facility: Medcenter One Health System
state: North Dakota
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital
state: Ohio
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Mayo Clinic
name: Steven R. Alberts, MD
role: STUDY_CHAIR
References:
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. doi: 10.1097/COC.0b013e318219863b.
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.