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Phase II Open-Label Study of Sunitinib Malate (SUO11248) in Adult Subjects With Metastatic and/or Surgically Unresectable Hepatocellular Cancers (HCC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

Thank you

Trial Information

Phase II Open-Label Study of Sunitinib Malate (SUO11248) in Adult Subjects With Metastatic and/or Surgically Unresectable Hepatocellular Cancers (HCC)


An open label multi-site phase II clinical trial of sunitinib malate given orally once daily
on days 1-28 of each 42-day cycle. Sunitinib malate will be dispensed as capsules at the
beginning of each treatment cycle. The dose may be escalated at the investigator's
discretion. Treatment will be continued until there is either disease progression or
cumulative or acute toxicity which in the opinion of the treating physician compromises the
ability of the patient to receive treatment or patient desire to stop treatment.

A follow up visit will be required before the beginning of every cycle every 6 weeks to
assess toxicity and for physical examination. Complete blood count (CBC) and differential,
comprehensive metabolic panel (including liver function tests) and alpha-feto protein (when
indicated) will be obtained at every scheduled follow up visit.


Inclusion Criteria:



- Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or
surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.

- Adequate organ function as defined by the following criteria:

- Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase
(SGOT) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase
(SGPT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN),
or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are
due to underlying malignancy

- Total serum bilirubin less than or equal to 1.5 x ULN

- Absolute neutrophil count (ANC) more than or equal to 1500/mcL

- Platelets more than or equal to 100,000/mcL

- Hemoglobin more than or equal to 9.0 g/dL

- Serum calcium less than or equal to 12.0 mg/dL

- Serum creatinine less than or equal to 1.5 x ULN

- Biopsy-proven disease

- Measurable disease radiographically

- Disease that is deemed surgically unresectable (awaiting orthotopic hepatic
transplantation allowable) and/or metastatic

- Age greater or equal to 18 years

- Life expectancy greater than 16 weeks

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky
score > 60%)

Exclusion Criteria:

- Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the
study treatment

- NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment

- History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening
computed tomography (CT) or magnetic resonance imaging (MRI) scan

- Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.

- Known brain metastases

- Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2

- Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2, atrial
fibrillation of any grade, or prolongation of the QTc interval to > 450msec for males
or > 470 msec for females

- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal
medical therapy)

- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness or other active infection

- Concurrent treatment on another clinical trial; supportive care trials or
non-treatment trials, e.g. Quality of Life (QOL), are allowed

- Concomitant use of ketoconazole or other agents known to induce CYP3A4

- Concomitant use of theophylline and phenobarbital and/or other agents metabolized by
the cytochrome P450 system

- Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg po
daily for thrombo prophylaxis is allowed)

- Pregnancy or breastfeeding. Female subjects must be surgically sterile or be
postmenopausal, or must agree to use effective contraception during the period of
therapy. All female subjects with reproductive potential must have a negative
pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically
sterile or must agree to use effective contraception during the period of therapy.
The definition of effective contraception will be based on the judgment of the
principal investigator or a designated associate.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and
in the judgment of the investigator would make the subject inappropriate for entry
into this study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Partial Response (PR) at Interim Analysis

Outcome Description:

Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].

Outcome Time Frame:

On Treatment to Off Study - average of 7 months per participant

Safety Issue:

No

Principal Investigator

Jonathan Strosberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-14733

NCT ID:

NCT00495625

Start Date:

October 2006

Completion Date:

December 2010

Related Keywords:

  • Liver Cancer
  • Hepatocellular cancer (HCC)
  • Sunitinib malate
  • Vascular endothelial growth factor (VEGF)
  • Platelet-derived growth factor (PDGF)
  • Tyrosine kinases
  • Liver
  • Liver Neoplasms

Name

Location

H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612