NCT00054262

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have unresectable liver cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 18, 2013

Status Verified

September 1, 2010

Enrollment Period

1.3 years

First QC Date

February 5, 2003

Last Update Submit

July 17, 2013

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver canceradvanced adult primary liver canceradult primary hepatocellular carcinoma

Interventions

T900607DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable hepatocellular carcinoma (HCC) * Bidimensionally measurable disease defined as at least 1 lesion that is 1 cm or more in 2 dimensions by CT scan * Class A or B Child-Pugh liver classification * No prior CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3\* * Platelet count at least 100,000/mm\^3\* * Hemoglobin at least 8.5 g/dL\* NOTE: \*More than 7 days since prior blood transfusions or growth factors Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Albumin greater than 2.5 g/dL * AST and ALT no greater than 3 times ULN * INR no greater than 1.5 (unless receiving anticoagulants) Renal * Creatinine no greater than 2 times ULN Cardiovascular * LVEF at least 50% * No New York Heart Association class III or IV cardiac disease * No acute anginal symptoms Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * No severe concurrent disease, infection, or co-morbidity that would preclude study entry * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for HCC * No concurrent therapeutic biological response modifier Chemotherapy * No prior chemotherapy for HCC * No prior chemoembolization for HCC * No other concurrent cytotoxic chemotherapy Endocrine therapy * At least 6 weeks since prior hormonal therapy (an indicator lesion must exist outside the area of therapy * No concurrent hormonal anticancer therapy Radiotherapy * No prior radiotherapy for HCC * At least 6 weeks since prior radiofrequency ablation, selective internal radiation, or embolization (an indicator lesion must exist outside the area of therapy) * No concurrent radiotherapy (including palliative therapy) Surgery * At least 6 weeks since prior surgical resection (an indicator lesion must exist outside the area of therapy) * Recurrence at the margin of the surgical resection is allowed * At least 6 weeks since prior cryosurgery * More than 4 weeks since other prior major surgery Other * More than 4 weeks since prior investigational therapy * At least 6 weeks since prior intratumoral ethanol injection (an indicator lesion must exist outside the area of therapy) * No other concurrent investigational anticancer therapy

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

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-1714, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

T 900607

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joanna M. Brell, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

November 1, 2002

Primary Completion

March 1, 2004

Study Completion

September 1, 2010

Last Updated

July 18, 2013

Record last verified: 2010-09

Locations

US(1)