Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | June 25, 2007 | ||||||||
Last Updated Date | September 19, 2012 | ||||||||
Start Date ICMJE | May 2007 | ||||||||
Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Resectability rate [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE |
Resectability rate | ||||||||
Change History | Complete list of historical versions of study NCT00492999 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver | ||||||||
Official Title ICMJE | A Phase II Study of the Rate of Conversion to Complete Resection in Patients With Initially Inoperable Hepatic-Only Metastases From Colorectal Cancer After Treatment With Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy | ||||||||
Brief Summary | RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver. |
||||||||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is an open-label, nonrandomized study. Patients are assigned to 1 of 2 treatment groups according to receipt of more than 2 prior courses of oxaliplatin (no vs yes).
In both groups, patients may undergo complete resection of liver metastases after completion of at least 3 courses of therapy. Some patients undergo blood and tissue collection periodically for correlative and immunological studies. Samples are analyzed for VEGF receptor VEGFR1, VEGFR2, VEGFR3, thymidylate synthase, p53, p21, topoisomerase 1, dihydropyrimidine dehydrogenase, and excision repair cross-complementing gene levels. After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arm (s) |
|
||||||||
Publications * | |||||||||
* 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 | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 64 | ||||||||
Estimated Completion Date | May 2013 | ||||||||
Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00492999 | ||||||||
Other Study ID Numbers ICMJE | 06-075, MSKCC-06075 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||||||
Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
Verification Date | September 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |