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 ]

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions


Original Primary Outcome: Overall response rate

Current Secondary Outcome: Overall Survival [ Time Frame: 18 months ]

Length of time, in months, that patients were alive from their first date of protocol treatment until death.


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