CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Oxaliplatin +1 moredrug
Likely dose
Oxaliplatin 130 mg/m² IV day 1 of 21-day cycle; Capecitabine 1000 mg/m² orally twice daily days 1-14 of each 21-day cycleAI-extracted
Key inclusion· 8
  • ✓Histologically confirmed carcinoma of unknown primary site
  • ✓Progressive disease after one prior chemotherapy regimen
  • ✓Prior treatment with one immunotherapy or biotherapy regimen
  • ✓No prior oxaliplatin, capecitabine, or 5-FU exposure
Key exclusion· 8
  • ✕Age <18 years
  • ✕Prior invasive malignancy within last 5 years
  • ✕Coexistent medical illnesses
  • ✕Clinically significant cardiac disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00193609
NCT00193609Phase 2Completed
CompareCT.gov

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

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Nov 11, 2013

In Brief

A Phase 2 clinical trial evaluating Oxaliplatin and Capecitabine for Neoplasms, Unknown Primary. Completed, enrolled 48 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Unknown Primary
CountriesUnited States
CollaboratorsRoche Pharma AG, Sanofi-Synthelabo

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartSep 1, 2004
Primary CompletionApr 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.8 years ago

Interventions

Oxaliplatindrug

130 mg/m2 IV day 1 of 21 day cycle

Capecitabinedrug

1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle