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	Treatment or Intervention	Phase
localized unresectable adult primary liver cancer advanced adult primary liver cancer adult primary hepatocellular carcinoma	Drug: T900607  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Joanna M. Brell, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000270198; CWRU-100211; TULA-TULI-2202; TULA-T-607-004
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054262
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08