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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00550719 |
RATIONALE: AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.
PURPOSE: This phase II trial is studying AZD6244 to see how well it works in treating patients with locally advanced or metastatic liver cancer.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: MEK inhibitor AZD6244 Procedure: biopsy Procedure: high performance liquid chromatography Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of AZD6244 in Advanced or Metastatic Hepatocellular Carcinoma |
Estimated Enrollment: | 44 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive a single dose of AZD6244 on day 1 and undergo blood collection for pharmacokinetic (PK) sampling pre-dose (within 30 min of dosing), 15 and 30 minutes and 1, 2, 4, 8, 12, 24 and 48 hours post-dose. Beginning 48 hours after the initial dose and continuing until day 21, patients receive oral AZD6244 twice daily. Patients also undergo blood collection for PK sampling on day 15 of course 1. In all subsequent courses, patients receive AZD6244 on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
AZD6244 blood concentrations are quantified by high performance liquid chromatography. Patients also undergo tumor biopsy by CT or ultrasound guidance at baseline and on day 8. Peripheral blood mononuclear cells and tumor tissue are evaluated for mitogen-activated protein kinase baseline activity and post-treatment activity.
After completion of study treatment, patients are followed periodically for up to 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Serum alpha fetoprotein > 1000 ng/dL with characteristic imaging findings coupled with the appropriate clinical scenario (i.e., chronic hepatitis and/or cirrhosis)
Child's A or B cirrhosis allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemoembolization, radioemboliaztion (90Y microspheres), resection, or radiofrequency/cryoablation
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: John S. Kauh, MD 404-778-2407 | |
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7305 | |
Contact: Bert H. O'Neil, MD 919-843-7180 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
United States, Virginia | |
Virginia Commonwealth University Massey Cancer Center | Recruiting |
Richmond, Virginia, United States, 23298-0037 | |
Contact: Ruey-min Lee, MD, PhD 804-828-9723 rlee5@vcu.edu |
Study Chair: | Bert H. O'Neil, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000571751, MCC-15260, MCC-07-0973, GCRC-2625-ORC, VU-VICC-GI-0726, 77782 |
Study First Received: | October 25, 2007 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00550719 |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Recurrence Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |