SU011248 in Advanced Hepatocellular Carcinoma

NCT ID: NCT00361309

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-03-31

Brief Summary

The main purpose of this study is to begin to collect information and try to learn whether SU011248 works in treating patients with advanced liver cancer. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further.

Detailed Description

• Participants will be given a supply of SU011248 capsules to be taken orally every morning for 4 weeks. After taking SU011248 for 4 weeks, there will be a 2 week rest period when the participant will not take any capsules. This 6-week period is referred to as 1 cycle.
• Participants will continue to receive SU011248 study treatment as long as their disease does not worsen significantly and they are not experiencing any serious side effects.
• During cycle 1 of study treatment, the participant will come to the outpatient clinic once a week for blood work, physical examination and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI), which is done two weeks after they start taking study treatment.
• During cycle two and every cycle thereafter, the participant will be asked to come to the outpatient clinic once every two weeks for physical examination, blood work and urine tests.
• A CT scan or MRI scan to assess the tumor will be performed once during each cycle for the first three cycles, then once every 2 cycles thereafter. ACTH stimulation test will be done every 2 cycles. A MUGA scan may be done at anytime at the discretion of the the study doctor.

Conditions

Hepatocellular Carcinoma; Liver Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SU011248

Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks). Patients will be continued on treatment until disease progression, limiting toxicity, or patient withdrawal of consent.

Group Type: EXPERIMENTAL

SU011248

Intervention Type: DRUG

Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks).

Interventions

SU011248

Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks).

Intervention Type: DRUG

Other Intervention Names

Sunitinib

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed HCC and should have metastatic or locally advanced unresectable disease
• Measurable disease
• 0-1 prior systemic chemotherapy regimens for HCC
• Age 18 years or older
• Life expectancy of greater than 12 weeks
• ECOG performance status of 0-1
• Adequate organ and marrow function
• Women of child-bearing potential must have a negative pregnancy test prior to study entry

Exclusion Criteria

• Chemotherapy, radiotherapy or major surgery within 4 weeks of study entry
• Receiving any other investigational agents within past 30 days
• Known brain metastases
• CLIP score > 3
• Chronic diarrhea or any disorder that will limit adequate absorption of SU011248
• Prolongation of QTc > 450 msec in screening electrocardiogram or history of familial long QT syndrome
• Uncontrolled intercurrent illness
• Pregnant or lactating women
• Greater than or equal to 2g of protein/24hr

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew X. Zhu, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew X. Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Sahani DV, Jiang T, Hayano K, Duda DG, Catalano OA, Ancukiewicz M, Jain RK, Zhu AX. Magnetic resonance imaging biomarkers in hepatocellular carcinoma: association with response and circulating biomarkers after sunitinib therapy. J Hematol Oncol. 2013 Jul 10;6:51. doi: 10.1186/1756-8722-6-51.

Reference Type: DERIVED

PMID: 23842041 (View on PubMed)

Other Identifiers

05-348

Identifier Type: -

Identifier Source: org_study_id