T900607 in Treating Patients With Unresectable Liver Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054262
First received: February 5, 2003
Last updated: July 17, 2013
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Drug: T900607
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2002
Study Completion Date: September 2010
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054262

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-1714
Sponsors and Collaborators
University Hospitals Seidman Cancer Center
Investigators
Study Chair: Joanna M. Brell, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054262     History of Changes
Other Study ID Numbers: TULA-TULI-2202, CWRU-100211, CDR0000270198, TULA-T-607-004
Study First Received: February 5, 2003
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 23, 2014