T900607 in Treating Patients With Unresectable Liver Cancer

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054262
• Other study ID #: TULA-TULI-2202
• Secondary ID: CWRU-100211CDR00
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: July 17, 2013
• Start date: November 2002
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• T900607

Locations

Country	Name	City	State
United States	Ireland Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Seidman Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,