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Status:

COMPLETED

TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Taiho Pharmaceutical Co., Ltd.

Conditions:

Liver Cancer

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

PHASE2

Brief Summary

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...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2001

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2005

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00077142

    Start Date

    April 1 2001

    End Date

    August 1 2005

    Last Update

    October 31 2018

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    MD Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009