T900607 in Treating Patients With Unresectable Liver Cancer

July 17, 2013 updated by: University Hospitals Seidman Cancer Center

A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the complete and partial response rates of patients with chemotherapy-naïve unresectable hepatocellular carcinoma treated with T900607.
  • Determine the efficacy of this drug, in terms of duration of response and time to disease progression, in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the safety profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive T900607 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-1714
        • Ireland Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Seidman Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Joanna M. Brell, MD, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TULA-TULI-2202
  • CWRU-100211
  • CDR0000270198 (Registry Identifier: PDQ (Physician Data Query))
  • TULA-T-607-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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