Expired Study
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Houston, Texas 77030


Purpose:

RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to see how well it works in treating patients with advanced hepatocellular carcinoma (liver cancer).


Study summary:

OBJECTIVES: Phase I - Primary - Determine the maximum tolerated dose (MTD) of TAC-101 in patients with advanced hepatocellular carcinoma. - Determine the safety of 2 consecutive courses of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the toxic and adverse effects profile of this drug in these patients. Phase II - Primary - Determine the objective antitumor response rate in patients treated with this drug at the MTD. - Secondary - Determine the overall survival time of patients treated with this drug. - Determine the time to disease progression in patients treated with this drug. - Determine the duration of observed objective response, using WHO criteria and measurements of serum alpha-fetoprotein concentrations, in patients treated with this drug. - Determine the time to treatment failure in patients treated with this drug. - Determine the safety and tolerability of intermittent treatment with this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. - Phase I: Patients receive oral TAC-101 once daily on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of TAC-101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive oral TAC-101 at the MTD (determined in phase I) once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 35-60 days. PROJECTED ACCRUAL: A total of 6-18 patients for the phase I portion and 21-41 patients for the phase II portion will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed hepatocellular carcinoma - At least 1 previously unirradiated, bidimensionally measurable lesion greater than 20 mm by MRI or conventional CT scan OR at least 10 mm by spiral CT scan - Patients with CNS involvement must have completed appropriate treatment and have no progressive neurologic deficits within the past 28 days - No carcinomatous meningitis PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - ECOG 0-2 Life expectancy - More than 12 weeks Hematopoietic - Hemoglobin ≥ 10.0 g/dL - WBC ≥ 2,000/mm^3 - Absolute neutrophil count ≥ 1,000/mm^3 - Platelet count ≥ 40,000/mm^3 - No abnormal bleeding or clotting Hepatic - No grade C Child-Pugh cirrhosis - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Albumin ≥ 2.8 g/dL - INR ≤ 1.5 times ULN - Bilirubin ≤ 2.0 mg/dL Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No prior deep vein thrombosis - No prior superficial venous thrombosis - No family history of thromboembolism in a first-degree relative - No lower extremity thromboses by Doppler ultrasound (unless a subsequent venous angiography confirms a false positive ultrasound) Pulmonary - No prior pulmonary embolism Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception, except oral contraceptives containing estrogen - Fasting triglycerides ≤ 400 mg/dL for men or ≤ 325 mg/dL for women - No other malignancy within the past 3 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix - No uncontrolled metabolic disorders, other nonmalignant organ or systemic disease, or secondary effects of cancer that induce a high medical risk - No known allergy or hypersensitivity to TAC-101 or its components PRIOR CONCURRENT THERAPY: Biologic therapy - No prior thalidomide - No prior putative antiangiogenesis therapy - Prior interferon allowed Chemotherapy - No more than 2 prior chemotherapy regimens Endocrine therapy - No concurrent estrogen products Radiotherapy - See Disease Characteristics - More than 21 days since prior radiotherapy, except small portal radiotherapy used for the palliation of isolated, symptomatic, osseous metastases - No prior radiotherapy to evaluable lesions - No concurrent radiotherapy unless for bone pain that is present before beginning study Surgery - Not specified Other - Prior anticancer treatment allowed provided there is clear evidence of progressive disease after the most recent treatment - More than 21 days since prior anticancer therapy and recovered - No more than 2 prior treatment regimens - No concurrent therapeutic anticoagulants - Concurrent low-dose warfarin for prophylactic care of indwelling venous access devices allowed - No concurrent azoles or tetracyclines - No concurrent medications known or suspected to increase risk of venous thromboembolism - No other concurrent retinoids


NCT ID:

NCT00077142


Primary Contact:

Study Chair
Melanie B. Thomas, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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