NCT00193609

Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site

A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Neoplasms, Unknown Primary

Interventions

Type	Name	Description
DRUG	Oxaliplatin	130 mg/m2 IV day 1 of 21 day cycle
DRUG	Capecitabine	1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-04-01
• Completion: 2009-01-01
• First posted: 2005-09-19
• Last updated: 2013-11-11
• Results posted: 2013-10-21

Locations

10 sites across 1 country: United States