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Clinical Trials/NCT00316420
NCT00316420
Completed
Phase 1

Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma

Swedish Medical Center1 site in 1 country20 target enrollmentDecember 2003
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ConditionsPancreatic Cancer
DrugsCapecitabine (Xeloda)Gemcitabine

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Swedish Medical Center
Enrollment
20
Locations
1
Primary Endpoint
MTD and DLT for the combination therapy of gemcitabine and capecitabine
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.

Registry
clinicaltrials.gov
Start Date
December 2003
End Date
August 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Metastatic or unresectable pancreatic cancer
  • •No prior chemotherapy except radiation-sensitizing doses of 5-FU
  • •No radiotherapy less than 4 weeks prior to the start of the study

Exclusion Criteria

  • •Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
  • •Moderate to severe renal impairment
  • •Uncontrolled diabetes
  • •Inability to swallow tablets

Outcomes

Primary Outcomes

MTD and DLT for the combination therapy of gemcitabine and capecitabine

Time Frame: January 2010

Secondary Outcomes

  • Tumor Response(January 2010)

Study Sites (1)

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