search
Back to results

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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAC-101
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, Oral TAC-101

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MD Anderson Cancer Center at University of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAC-101

Arm Description

Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of TAC-101

Secondary Outcome Measures

Full Information

First Posted
February 10, 2004
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), Taiho Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00077142
Brief Title
TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
Official Title
Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 in treating patients with advanced hepatocellular carcinoma (liver cancer).
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, Oral TAC-101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAC-101
Arm Type
Experimental
Arm Description
Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.
Intervention Type
Drug
Intervention Name(s)
TAC-101
Intervention Description
Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of TAC-101
Time Frame
60 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie B. Thomas, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18504614
Citation
Higginbotham KB, Lozano R, Brown T, Patt YZ, Arima T, Abbruzzese JL, Thomas MB. A phase I/II trial of TAC-101, an oral synthetic retinoid, in patients with advanced hepatocellular carcinoma. J Cancer Res Clin Oncol. 2008 Dec;134(12):1325-35. doi: 10.1007/s00432-008-0406-2. Epub 2008 May 27.
Results Reference
result
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

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

We'll reach out to this number within 24 hrs