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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01260194
First received: December 13, 2010
Last updated: September 1, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: trastuzumab [Herceptin]
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: June 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260194

Locations
India
Bangalore, India, 560027
Bangalore, India, 560029
Nagpur, India, 440012
New Delhi, India, 110085
Noida, India, 201 301
Vishakpatnam, India, 530002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01260194     History of Changes
Other Study ID Numbers: ML25477
Study First Received: December 13, 2010
Last Updated: September 1, 2015
Health Authority: India: Drug Controller General

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015