Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

This study has been completed.

Sponsor:

Collaborator:

Roche Pharma AG

Information provided by:

Swedish Medical Center

ClinicalTrials.gov Identifier:

NCT00316420

First received: April 18, 2006

Last updated: March 4, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2006

Last Updated Date

March 4, 2010

Start Date ^ICMJE

December 2003

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

MTD and DLT for the combination therapy of gemcitabine and capecitabine [ Time Frame: January 2010 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00316420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tumor Response [ Time Frame: January 2010 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

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

Other Name: Xeloda
Drug: Gemcitabine
750 mg/m2 IV Days 1 & 8 q 21 days

Other Name: Gemzar

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00316420

Other Study ID Numbers ^ICMJE

TI027 PG/HK

Has Data Monitoring Committee

Responsible Party

Philip Gold, M.D., Swedish Medical Center, Swedish Cancer Insitute

Study Sponsor ^ICMJE

Swedish Medical Center

Collaborators ^ICMJE

Roche Pharma AG

Investigators ^ICMJE

Principal Investigator:	Philip Gold, MD	Swedish Medical Center Cancer Institute
Principal Investigator:	Henry Kaplan, MD	Swedish Medical Center Cancer Institute

Information Provided By

Swedish Medical Center

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top