A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

An Open-label Pilot Study of Herceptin Monotherapy on Objective Treatment Response in Patients With Metastatic or Locally Advanced Gastric Cancer Who Had Disease Progression During Platinum-based or 5-fluoropyrimidine-based Chemotherapy

This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.

Study Overview

• Status: Terminated
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Trastuzumab

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
• Germany
  • Dresden, Germany, 01307
  • Erlangen, Germany, 91054
  • Essen, Germany, 45122
  • Grenzach-wyhlen, Germany, 79639
  • Halle, Germany, 06120
  • Kassel, Germany, 34125
  • Kiel, Germany, 24105
  • Mannheim, Germany, 68167
  • München, Germany, 81675
  • München, Germany, 81377
  • Oldenburg, Germany, 26133

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients 18-75 years of age;
• metastatic or advanced gastric cancer;
• disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
• >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
• >=1 measurable lesion;
• HER2 overexpression (IHC [2+] or [3+]).

Exclusion Criteria:

• concurrent chemotherapy or immunotherapy;
• brain or meningeal metastases;
• clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
• co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
• women who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trastuzumab Monotherapy; Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit	Drug: Trastuzumab; 4 mg/kg initial dose, followed by 2 mg/kg; Other Names: Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).	Weekly throughout study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Benefit	Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD. Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable SD: not qualifying for CR, PR, or PD.	Weekly throughout the study
Percentage of Participants With a Best Overall Response of CR or PR	Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.	Weekly throughout the study
Overall Survival - Number of Participants Who Died	OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.	Weekly throughout the study
Overall Survival	Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.	Weekly throughout the study
Time to Progression - Number of Participants With an Event	Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.	Weekly throughout the study
Time to Progression	Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.	Weekly throughout the study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Disease Progression; Stomach Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: ML17263