Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2015-01-31

Brief Summary

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The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.

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Detailed Description

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Conditions

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Neoplasms, Gastrointestinal Tract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lapatinib and Capecitabine

oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has signed inform consent
* Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer, including the gastro-esophageal junction
* Tumor accessible to and patient consent for endoscopic biopsy at study start and after 7 days of single agent Lapatinib
* Measurable disease according to RECIST criteria
* Male or female \> or = 18 years of age
* Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
* must have adequate organ function as defined by baseline laboratory values

Exclusion Criteria

* Gastric carcinoid, sarcomas, or squamous cell cancer
* Pregnant or lactating females
* Intractable nausea, vomiting, or gastro intestinal obstruction requiring decompression and drainage with a gastric tube or nasogastric suction.
* patients who require continuous enteral feeding
* Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative colitis
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No