SU011248 in Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361309
• Other study ID #: 05-348
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2006
• Last updated: March 16, 2014
• Start date: April 2006
• Est. completion date: March 2009

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.		2 years	No
Secondary	Number of adverse events in patients treated with SU011248 for advanced hepatocellular carcinoma		2 years	Yes
Secondary	Objective Response Rate		2 years	No
Secondary	Overall Survival		2 years	No