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T900607 in Treating Patients With Unresectable Liver Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00054262
Enrollment
Unknown
Registered
2003-02-06
Start date
2002-11-30
Completion date
2010-09-30
Last updated
2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

Brief summary

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

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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University Hospitals Seidman Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026