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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01260194
First received: December 13, 2010
Last updated: October 20, 2014
Last verified: October 2014

December 13, 2010
October 20, 2014
June 2011
August 2018   (final data collection date for primary outcome measure)
Median progression free survival according to tumor assessments [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01260194 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
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

This open-label, multi-center study will evaluate the efficacy and safety of Her ceptin (trastuzumab) in combination with standard chemotherapy as first-line tre atment in patients with HER2 positive metastatic adenocarcinoma of the stomach o r 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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
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
Experimental: 1
Intervention: Drug: trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2018
August 2018   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Reference Study ID Number: ML25477 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
India
 
NCT01260194
ML25477
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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