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

NCT00526669 | Completed Phase 2 Results

• 1 other identifier: LPT109747
• Study Type: interventional
• Target: 68
• Locations: 6 countries
• Sites: 22

Brief Summary

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.

Conditions

Neoplasms, Gastrointestinal Tract

Keywords

tumor biopsy; capecitabine; first line; Gastro Esophageal (GE) Junction Cancer; Gastric cancer; newly diagnosed; GE junction; lapatinib; metastatic or unresectable

Outcome Measures

Primary Outcomes (3)

• Change From Start of Run-in Period in Biomarker Expression Levels at Day 0

  Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.

  evaluated at baseline and after 7 days of study treatment

• Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])

  Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as \>= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.

  From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)

• Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)

  5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of \>=1 NL and/or unequivocal progression of existing non-TLs, and a \>=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.

  From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)

Secondary Outcomes (23)

• PFS

  From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)

• Overall Survival (OS)

  From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)

• Time to Progression (All Deaths Are Treated as Competing Risk)

  From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)

• Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)

  From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)

• Time to Response

  Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)

Interventions

Lapatinib and Capecitabine DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Loma Linda, California, 92354, United States

Location

GSK Investigational Site

Los Angeles, California, 90033, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71103, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

GSK Investigational Site

Southgate, Michigan, 48195, United States

Location

GSK Investigational Site

Jefferson City, Missouri, 65109, United States

Location

GSK Investigational Site

Dallas, Texas, 75137, United States

Location

GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

GSK Investigational Site

Mexico City, CP 14080, Mexico

Location

GSK Investigational Site

Astrakhan, 414044, Russia

Location

GSK Investigational Site

Chelyabinsk, 454087, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Ufa, 450054, Russia

Location

GSK Investigational Site

Hwasun, 519-809, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Suwon, Gyeonggi-do, 442-723, South Korea

Location

GSK Investigational Site

Changhua, 500, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 104, Taiwan

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

Related Publications (1)

• LaBonte MJ, Yang D, Zhang W, Wilson PM, Nagarwala YM, Koch KM, Briner C, Kaneko T, Rha SY, Gladkov O, Urba SG, Sakaeva D, Pishvaian MJ, Hsieh RK, Lee WP, Lenz HJ. A Phase II Biomarker-Embedded Study of Lapatinib plus Capecitabine as First-line Therapy in Patients with Advanced or Metastatic Gastric Cancer. Mol Cancer Ther. 2016 Sep;15(9):2251-8. doi: 10.1158/1535-7163.MCT-15-0908. Epub 2016 Jun 20.

  PMID: 27325685 DERIVED

MeSH Terms

Conditions

Neoplasms; Stomach Neoplasms; Neoplasm Metastasis

Interventions

Lapatinib; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: March 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: January 1, 2015
• Last Updated: January 29, 2016
• Results First Posted: October 1, 2012

Record last verified: 2015-07

Locations

ME (1); CA (1); US (8); RU (4); KR (4); TW (4)