Clinical trial · Interventional
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
NCT00006010CI-TRIAL-00025071completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: docetaxel
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- six-month overall survival
- timeFrame
- at 6 months
Secondary outcomes (2)
- measure
- tumor response
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAlberts 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. PMID 21555932
- RESULTKim 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.