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

NCT01260194 | Terminated Phase 4 Results

• 1 other identifier: ML25477
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 6

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival (PFS)

  The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first. PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters \[mm\]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The censoring date was the last date of "last tumor measurement," "last date of study drug treatment," or "last follow-up." The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method.

  Baseline up to PD or death (maximum up to 22 months)

Secondary Outcomes (8)

• Overall Survival (OS)

  Baseline up to death (maximum up to 22 months)

• Percentage of Participants With Overall Tumor Response

  Baseline up to PD or death (maximum up to 22 months)

• Percentage of Participants With Clinical Benefit Response (CBR)

  Baseline up to PD or death (maximum up to 22 months)

• Duration of Response (DR)

  Baseline up to PD or death (maximum up to 22 months)

• Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline up to 6 month after last dose of study drug (maximum up to 22 months)

Study Arms (1)

1

EXPERIMENTAL

Drug: trastuzumab [Herceptin]

Interventions

trastuzumab [Herceptin] DRUG

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

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Bangalore, Karnataka, 560027, India

Location

Unknown Facility

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Unknown Facility

Bangalore, 560029, India

Location

Unknown Facility

Nagpur, 440012, India

Location

Unknown Facility

Noida, 201 301, India

Location

Unknown Facility

Vishakpatnam, 530002, India

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: June 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 2, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-11

Locations

IN (6)