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.
- 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.
- 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
- 18 and over
- Karnofsky 70-100%
- At least 12 weeks
- 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
- 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)
- Creatinine no greater than 2 times ULN
- LVEF at least 50%
- No New York Heart Association class III or IV cardiac disease
- No acute anginal symptoms
- 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
- 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:
- No prior immunotherapy for HCC
- No concurrent therapeutic biological response modifier
- No prior chemotherapy for HCC
- No prior chemoembolization for HCC
- No other concurrent cytotoxic chemotherapy
- At least 6 weeks since prior hormonal therapy (an indicator lesion must exist outside
the area of therapy
- No concurrent hormonal anticancer therapy
- 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)
- 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
- 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