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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006010
• Other study ID #: NCCTG-N0041
• Secondary ID: NCI-2012-02349CD
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: December 5, 2016
• Start date: September 2001
• Est. completion date: April 2008

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2008
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• docetaxel

• gemcitabine hydrochloride

Locations

Country	Name	City	State
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	Mayo Clinic	Jacksonville	Florida
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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 — View 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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six-month overall survival		at 6 months	No
Secondary	tumor response		Up to 5 years	No
Secondary	time to progression		Up to 5 years	No