A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01260194

First received: December 13, 2010

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2010

Last Updated Date

May 7, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

February 2019 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Median progression free survival according to tumor assessments [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01260194 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Median overall survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Clinical benefit rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Laboratory tests (hematology, biochemistry), graded according to National Cancer Institute-Common Toxicity Criteria (NCI-CTC) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Left Ventricle Ejection Fraction (LVEF) as measured by echocardiography [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Her2 status (+/-) in gastric cancer across 11 centers in India as assessed by immunohistochemistry [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer

Official Title ^ICMJE

An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer

Brief Summary

This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

Drug: trastuzumab [Herceptin]

Loading dose of 8 mg/kg on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression in combination with standard chemotherapy

Study Arm (s)

Experimental: 1

Intervention: Drug: trastuzumab [Herceptin]

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2019

Estimated Primary Completion Date

February 2019 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, >/=18 years of age
Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
HER2 positive tumor (primary tumor or metastasis
ECOG Performance status 0, 1 or 2
Life expectancy of at least 3 months

Exclusion Criteria:

Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
Patients with active (significant or uncontrolled) gastrointestinal bleeding
Residual relevant toxicity resulting from previous chemotherapy
Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: ML25477 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT01260194

Other Study ID Numbers ^ICMJE

ML25477

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

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

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