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Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Trial Status: active
This phase 1 study is to determine the optimal dose and tolerability of a
hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver
cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with
tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial
injection before embolization. Treatment effect is evaluated by MRI based on mRECIST
criteria. Repeat treatment is necessary only if disease progression. Dose escalation
cohort has been completed. Expansion cohort is open for metastatic liver dominant
neuroendocrine tumor.
Inclusion Criteria
Inclusion Criteria:
1. Patients with well-differentiated NET and liver-dominant metastatic disease with
intrahepatic disease progression, regardless of primary tumor origin or tumor
functional status. Patients may have extrahepatic lesions as long as the majority of
the disease burden is intrahepatic.
2. No limitation in hepatic lesion tumor size or number but the total volume of liver
tumors cannot exceed 50% of the liver volume.
3. Patients are allowed to have prior US Food and Drug Administration (FDA)-approved
treatments, including systemic therapies, surgery, ablation, or transarterial
therapies for the metastatic NET.
4. Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac,
pulmonary, or renal dysfunction.
5. Are candidates for TAE or TACE and without portal vein occlusion per treating
interventional radiologists.
6. ANC no less than 1000 /μL. Hemoglobin ≥ 9 gm/dL. Platelets no less than 50,000 /μL.
Creatinine no more than 2.0 mg/dL. AST, ALT no more than 5X upper limit of normal.
Bilirubin no more than 2.5 mg/dl. PT prolongation ≤ 4 sec above upper limit of
normal.
7. Woman of child-bearing potential (WOCBP) should use highly effective contraception
during trial participation and for 6 months after the last dose of tirapazamine and
men who are partners with WOCBP should use highly effective contraception, including
barrier contraception, during trial participation and for 3 months after the last
dose of tirapazamine.
Additional locations may be listed on ClinicalTrials.gov for NCT02174549.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based
on tolerability. Patients will receive escalated doses of tirapazamine until maximally
tolerated dose. Embolization is performed per standard practice using Lipiodol and
Gelfoam under X-ray guidance. Once a suitable dose is determined, an expansion cohort of
15 patients will be treated with the recommended phase 2 dose to determine preliminary
efficacy. Expansion cohorts include (1) hepatocellular carcinoma, (2) metastatic solid
tumors with liver metastasis, and (3) neuroendocrine tumor. Adverse events are evaluated
by CTCAE vs. 5.0 and efficacy is evaluated by MRI using modified RECIST criteria and
RECIST criteria.
The dose escalation part has been completed. Only the third cohort or neuroendocrine
tumor remains active for future patient enrollment.
