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Clinical Trials/EUCTR2006-003775-13-IT
EUCTR2006-003775-13-IT
Active, not recruiting
Not Applicable

A phase II study of Capecitabine in combination with Cisplatin in advanced head and neck Cancer - ND

OSPEDALE ONCOLOGICO DI BARI0 sites43 target enrollmentOctober 3, 2006
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ConditionsAdvanced or metastatic head and neck cancerLevel: HLTClassification code 10024530
DrugsXELODA*120CPR RIV 500MGCISPLATINO MAYNE*EV 100MG100ML

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced or metastatic head and neck cancer
Sponsor
OSPEDALE ONCOLOGICO DI BARI
Enrollment
43
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 3, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
OSPEDALE ONCOLOGICO DI BARI

Eligibility Criteria

Inclusion Criteria

  • •1\. Advanced loco\-regional and/or metastatic recurrence of head and neck squamous cell carcinoma histologically or cytologically proven 2\. No previous treatment with chemotherapy 3\. Age 18 and 75 years 4\. Life expectancy 3 months 5\. Normal cardiac function 6\. No gastrointestinal disorders that might affect the gastrointestinal absorption of Capecitabine
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. History of prior malignancy in the last 10 years 2\. Concurrent treatment with other experimental drugs or participation in another clinical trial with ant investigational drug within 30 days prior to study screening 3\. ASAT SGOT and/or ALAT SGPT 1\.5 x UNL associated with alkaline phosphatase 2\.5 x UNL 4\. Other serious illness or medical condition

Outcomes

Primary Outcomes

Not specified

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