T900607 in Treating Patients With Unresectable Liver Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: T900607


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: T900607|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma