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SU011248 in Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT00361309
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : March 18, 2014
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 4, 2006
First Posted Date  ICMJE August 8, 2006
Last Update Posted Date March 18, 2014
Study Start Date  ICMJE April 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2014)
Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2006)
To assess the progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.
Change History Complete list of historical versions of study NCT00361309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2014)
  • Number of adverse events in patients treated with SU011248 for advanced hepatocellular carcinoma [ Time Frame: 2 years ]
  • Objective Response Rate [ Time Frame: 2 years ]
  • Overall Survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2006)
  • To evaluate the toxicities of SU011248 in this patient population
  • to evaluate the preliminary efficacy of SU011248 including response rate, duration of response, and overall survival in this population.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SU011248 in Advanced Hepatocellular Carcinoma
Official Title  ICMJE A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Liver Cancer
Intervention  ICMJE 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).
Other Name: Sunitinib
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: SU011248
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2006)
34
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00361309
Other Study ID Numbers  ICMJE 05-348
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew X. Zhu, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
Investigators  ICMJE
Principal Investigator: Andrew X. Zhu, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP