NCT00103324

Brief Summary

This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

2.4 years

First QC Date

February 7, 2005

Last Update Submit

January 16, 2013

Conditions

Diffuse Adenocarcinoma of the StomachIntestinal Adenocarcinoma of the StomachMixed Adenocarcinoma of the StomachRecurrent Gastric CancerStage III Gastric CancerStage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Confirmed response probability (complete and partial)

    Up to 2 years

Secondary Outcomes (2)

  • Time to treatment failure

    From the date of registration to the date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment, assessed up to 2 years

  • Overall survival

    From date of registration to date of death due to any cause, assessed up to 2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: lapatinib ditosylateOther: laboratory biomarker analysis

Interventions

lapatinib ditosylateDRUG

Given orally

Also known as: GSK572016, GW-572016, GW2016, Lapatinib, Tykerb
Treatment
laboratory biomarker analysisOTHER

Correlative studies

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have cytologically or pathologically verified diagnosis of gastric cancer; patients must have locally advanced or distant metastatic disease (either recurrent or at primary diagnosis) that is not surgically curable
  • The pathologic confirmation of gastric cancer may be made from the metastatic site; biopsy of the primary tumor is not necessary; patients with pathologic confirmation of cancer from a metastatic site, along with clinical documentation of gastric involvement and no evidence of another primary are also eligible
  • Eligible pathologic type: patients may have any histological subtype including adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, intestinal type, clear cell adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, carcinoma NOS; patients must not have carcinoid tumors or sarcomas
  • Patients must have measurable disease; x-rays, scans, or physical examinations for measurable disease must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration,; all disease must be assessed
  • Patients must be willing to have specimens submitted; the paraffin embedded specimens must be available for submission
  • Patients may have had prior surgery for their gastric cancer; patients must be at least 2 weeks beyond surgery, and recovered from all effects of surgery
  • Patients may have received prior chemotherapy, hormonal therapy, immunotherapy, radiation or chemoradiotherapy as neoadjuvant or adjuvant treatment but this must have been completed at least 6 months prior to documented recurrence or metastatic disease; patients must not have received previous treatment for metastatic disease
  • If patient received radiation therapy, the site of measurable disease must be outside of the radiation field
  • Patients must not have had prior therapy with EGFR targeting therapies
  • Patients must have a Zubrod performance status of 0-1
  • Leukocytes \>= 3,000/mcl
  • Platelets \>= 100,000/mcl
  • AGC \>= 1,500/mcl
  • Serum transaminase (SGOT or SGPT) =\< 2.5 x IULN; patients with liver metastases must have SGOT/SGPT =\< 5 x IULN
  • Bilirubin =\< IULN
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

LapatinibN-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Syma Iqbal

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2005

First Posted

February 8, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2007

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)