Clinical Trial: Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site
Brief Summary: In this phase II trial, we will evaluate the feasibility and efficacy of the oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed after a previous response to treatment will be eligible, as well as those who were refractory to first-line therapy.
Detailed Summary: All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 PO BID was administered on days 1-14 of each cycle.
Sponsor: SCRI Development Innovations, LLC
Current Primary Outcome: Progression Free Survival [ Time Frame: 18 months ]
Original Primary Outcome: Overall response rate
Current Secondary Outcome: Overall Survival [ Time Frame: 18 months ]
Original Secondary Outcome:
- Progression-free survival
- Overall survival
Information By: SCRI Development Innovations, LLC
Dates:
Date Received: September 12, 2005
Date Started: September 2004
Date Completion:
Last Updated: October 18, 2013
Last Verified: October 2013