Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well AZD2171 works in treating patients with locally advanced or metastatic liver cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cediranib; Maleic acid

Criteria

Inclusion Criteria:

• Histologically confirmed hepatocellular carcinoma

• Locally advanced or metastatic disease

• Not amenable to treatment with surgery or orthotopic liver transplantation

• Measurable or non-measurable disease

• Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• Evidence of disease progression by imaging on serial exams or biochemical evidence of a rising alpha fetoprotein on serial testing

• No history of brain metastases other than locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery)

• Patients with locally treatable CNS disease eligible provided they were previously treated and had no evidence of CNS progression for ≥ 4 weeks after completion of treatment

• No fibrolamellar hepatocellular carcinoma or mixed cholangiocarcinoma/hepatocellular carcinoma

• Performance status - ECOG 0-1

• Absolute neutrophil count ≥ 1,200/mm^3

• Platelet count ≥ 75,000/mm^3

• Hemoglobin ≥ 10.0 g/dL

• Bilirubin ≤ 3 times upper limit of normal (ULN)

• AST ≤ 5 times ULN

• Alkaline phosphatase ≤ 5 times ULN

• Urine protein < 1+ by urine dip stick OR proteinuria < 1 gm/24-hour collection

• QTc prolongation ≤ 500 msec

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No uncontrolled blood pressure, defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg

• No significant ECG abnormality within the past 14 days

• No New York Heart Association class III or IV disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No history of allergic reaction to compounds of similar chemical or biological composition to AZD2171

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study participation

• No other uncontrolled illness

• More than 4 weeks since prior biologic therapy

• More than 4 weeks since prior and no concurrent immunotherapy

• No colony-stimulating factors during the first course of study treatment

• At least 6 weeks since prior chemoembolization

• Patients must have evidence of disease progression or new metastases after prior chemoembolization

• No prior systemic chemotherapy for this cancer

• No other concurrent chemotherapy

• More than 4 weeks since prior hormonal therapy

• See Disease Characteristics

• At least 6 weeks since prior radiofrequency ablation or other local ablative therapy

• Patients must have evidence of disease progression or new metastases after prior radiofrequency ablation or other local ablative therapy

• No prior external beam radiotherapy to the primary site

• No prior radiotherapy to ≥ 25% of the bone marrow

• No concurrent radiotherapy

• See Disease Characteristics

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent drugs or biologics with proarrhythmic potential