A Phase II Study to Evaluate the Efficacy and Toxicity of Oxaliplatin in Combination With Gemcitabine as First and Second Line Therapy in Unknown Primary Cancer
Sponsor study identifier
interventional
29
1 country
1
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2007
Actual (reported)Study Completion
January 2010
Actual (reported)Primary objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 13, 2006
Actual (reported)July 17, 2006
Actual (reported)March 2007
Actual (reported)January 2010
Actual (reported)Participants' Response
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor increase to qualify for PD, reference smallest sum LD since treatment started.
Response to treatment measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria with radiological evaluation at 6 weeks and reevaluated every 6 weeks.
Gemcitabine 1000 mg/m\^2, infused at 10 mg/m\^2/min on Day 1 and Oxaliplatin 100 mg/m\^2 by vein infused on Day 2 over two hours. Repeated every 14 days (one cycle).
1000 mg/m\^2, infused at 10 mg/m\^2/min on Day 1 repeated every 14 days (one cycle).
100 mg/m\^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Carlson H, Lenzi R, Raber MN, Varadhachary GR. A phase II study to evaluate the efficacy and toxicity of oxaliplatin in combination with gemcitabine in carcinoma of unknown primary. Int J Clin Oncol. 2013 Apr;18(2):226-31. doi: 10.1007/s10147-011-0366-4. Epub 2012 Jan 5.
Gauri R. Varadhachary, MD
M.D. Anderson Cancer Center
29 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2006
First Posted
July 17, 2006
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Quality of Life Surveys
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Primary Completion
March 2007
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
August 2, 2012
Record last verified: 2012-08
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Source: ClinicalTrials.gov.
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