NCT00095992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2005

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
4 months until next milestone

Study Start

First participant enrolled

March 8, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2008

Completed
Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

November 9, 2004

Last Update Submit

August 3, 2023

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomaadvanced adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

  • Response

    4 years

Secondary Outcomes (3)

  • Toxicity

    4 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

Interventions

ispinesibDRUG

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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Knox JJ, Gill S, Synold TW, Biagi JJ, Major P, Feld R, Cripps C, Wainman N, Eisenhauer E, Seymour L. A phase II and pharmacokinetic study of SB-715992, in patients with metastatic hepatocellular carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG IND.168). Invest New Drugs. 2008 Jun;26(3):265-72. doi: 10.1007/s10637-007-9103-2. Epub 2008 Jan 15.

    PMID: 18196204RESULT

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

ispinesib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Jennifer Knox, MD

    Princess Margaret Hospital, Canada

    STUDY CHAIR

  • Sharlene Gill, MD

    British Columbia Cancer Agency

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

March 8, 2005

Primary Completion

September 26, 2006

Study Completion

September 22, 2008

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)