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SU011248 in Advanced Hepatocellular Carcinoma

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00361309
First received: August 4, 2006
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
Drug: SU011248
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events in patients treated with SU011248 for advanced hepatocellular carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Objective Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: April 2006
Study Completion Date: March 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361309

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Andrew X. Zhu, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew X. Zhu, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361309     History of Changes
Other Study ID Numbers: 05-348
Study First Received: August 4, 2006
Last Updated: March 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
liver cancer
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014