Gemcitabine and Capecitabine in Patients With Advanced Pa... | NCT00316420

Studies
Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

NCT00316420

Sponsor

Swedish Medical Center

Status

Completed

Last Update Posted

Mar 8, 2010Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Pancreatic Cancer

Interventions

Capecitabine (Xeloda)
Gemcitabine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Feb 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Apr 18, 2006

First Submission Date that Met QC Criteria

Apr 18, 2006

First Posted Date

Apr 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2010

Last Update Posted Date

Mar 8, 2010Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine (Xeloda)	Drug	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		Xeloda
Gemcitabine	Drug	750 mg/m2 IV Days 1 & 8 q 21 days		Gemzar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MTD and DLT for the combination therapy of gemcitabine and capecitabine		January 2010

Secondary Outcomes

Measure	Description	Time Frame
Tumor Response		January 2010

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Gold, MD	Swedish Medical Center Cancer Institute	Principal Investigator
Henry Kaplan, MD	Swedish Medical Center Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swedish Medical Center Cancer Institute		Seattle	Washington	98104	United States

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069287	Capecitabine
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided