Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00054262


Primary Contact:

Study Chair
Joanna M. Brell, MD
Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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