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Home > "T" Clinical Trials Conditions > TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)  TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
For Condition: advanced adult primary liver cancer,localized unresectable adult primary liver cancer,recurrent adult primary liver cancer,adult primary hepatocellular carcinoma
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of TAC-101 in treating patients who have advanced hepatocellular carcinoma (liver cancer).
Details: 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. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MelanieThomas, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Melanie Thomas 713-792-2828
Additional Information:
Study ID Numbers: CDR0000349508; MDA-ID-01007,NCI-1528,TAIHO-TAC101
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077142
Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer
2. Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
3. Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction
4. Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma Cancer
5. Thalidomide Plus Interferon alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
Related Studies:
Other localized unresectable adult primary liver cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
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