Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316420
• Other study ID #: TI027 PG/HK
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2006
• Last updated: March 4, 2010
• Start date: December 2003
• Est. completion date: August 2009

Study information

• Verified date: March 2010
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Capecitabine (Xeloda)
650 mg/m2 po bid Days 1-14 750 mg/m2 po bid Days 1-14 850 mg/m2 po bid Days 1-14 950 mg/m2 po bid Days 1-14
• Gemcitabine
750 mg/m2 IV Days 1 & 8 q 21 days

Locations

Country	Name	City	State
United States	Swedish Medical Center Cancer Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Medical Center	Roche Pharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD and DLT for the combination therapy of gemcitabine and capecitabine		January 2010	Yes
Secondary	Tumor Response		January 2010	No