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T900607 in Treating Patients With Unresectable Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
T900607
Sponsored by
University Hospitals Seidman Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
July 17, 2013
Sponsor
University Hospitals Seidman Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00054262
Brief Title
T900607 in Treating Patients With Unresectable Liver Cancer
Official Title
A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospitals Seidman Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
T900607

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna M. Brell, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1714
Country
United States

12. IPD Sharing Statement

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T900607 in Treating Patients With Unresectable Liver Cancer

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