Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

T900607 in Treating Patients With Unresectable Liver Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry CWRU-100211 TULA-TULI-2202, TULA-T-607-004, NCT00054262

Objectives

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

Entry 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

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

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/mm³*
• Platelet count at least 100,000/mm³*
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Joanna Brell, MD, Protocol chair		Ph: 216-844-6031 Email: joanna.brell@case.edu

Registry Information
Official Title		A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma
Trial Start Date		2002-11-21
Registered in ClinicalTrials.gov		NCT00054262
Date Submitted to PDQ		2002-12-23
Information Last Verified		2003-11-26
NCI Grant/Contract Number		P30-CA43703

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