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SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent Or Metastatic Hepatocellular Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00095992
Enrollment
15
Registered
2004-11-09
Start date
2005-03-08
Completion date
2008-09-22
Last updated
2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

Brief summary

RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.

Detailed description

OBJECTIVES: * Determine the efficacy of SB-715992, in terms of response rate and stable disease rate, in patients with locally advanced, recurrent, or metastatic hepatocellular carcinoma. * Determine the toxicity of this drug in these patients. * Determine the early progression rate and response duration in patients treated with this drug. * Determine the pharmacokinetics of this drug in these patients. * Correlate pharmacokinetics with safety and efficacy of this drug in these patients. * Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical outcomes in patients treated with this drug. OUTLINE: This is a non-randomized, multicenter study. Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients are followed at 4 weeks. Patients with ongoing stable or responding disease are followed every 3 months until relapse. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-14 months.

Interventions

SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatocellular carcinoma * Locally advanced, recurrent, or metastatic disease * Histologically confirmed disease must have archival paraffin-fixed tumor specimen available * Measurable disease * At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan * Outside of previously irradiated area * Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field * Bone metastases are not considered measurable disease * Not curable by standard therapies * No cholangiocarcinoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 80,000/mm\^3 Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST ≤ 5 times ULN * Must have hepatic reserve of Child-Turcotte-Pugh class A or better Renal * Creatinine clearance ≥ 60 mL/min Cardiovascular * No myocardial infarction within the past 6 months * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No active cardiomyopathy * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinical evidence of encephalopathy * No ongoing or active infection * No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992 * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered * Documented disease progression * No prior systemic chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy Surgery * At least 4 weeks since prior major surgery * Prior liver transplantation allowed Other * No other prior systemic therapy * At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or ethanol injection) and recovered * Documented disease progression * More than 28 days since prior investigational agents * More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers: * Clarithromycin * Erythromycin * Troleandomycin * Itraconazole * Ketoconazole * Fluconazole (dose \> 200 mg/day) * Voriconazole * Nefazodone * Fluvoxamine * Verapamil * Diltiazem * Grapefruit juice * Bitter orange * Phenytoin * Carbamazepine * Phenobarbital * Oxcarbazepine * Rifampin * Rifabutin * Rifapentine * Hypericum perforatum (St. John's wort) * Modafinil * At least 6 months since prior and no concurrent amiodarone * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer therapy * No other concurrent investigational agents

Design outcomes

Primary

MeasureTime frame
Response4 years

Secondary

MeasureTime frame
Toxicity4 years
Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is adjusted)4 years
Molecular correlates on archival tumor specimens and peripheral blood mononuclear cells (PBMCs)4 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026