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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02005484
• Other study ID #: ML17263
• Status: Terminated
• Phase: Phase 2
• First received: December 4, 2013
• Last updated: July 23, 2014
• Start date: January 2004
• Est. completion date: February 2008

Study information

• Verified date: July 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Federal Office for Safety in Health Care, BASG - AGES, Institut Zulassung & LCM/KPPS
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Disease Progression
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Trastuzumab
4 mg/kg initial dose, followed by 2 mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No