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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005484

Enrollment

Registered

2013-12-09

Start date

2004-01-31

Completion date

2008-02-29

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Brief 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.

Interventions

DRUGTrastuzumab

4 mg/kg initial dose, followed by 2 mg/kg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	Weekly throughout study	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).

Secondary

Measure	Time frame	Description
Percentage of Participants With a Best Overall Response of CR or PR	Weekly throughout the study	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.
Overall Survival - Number of Participants Who Died	Weekly throughout the study	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.
Percentage of Participants With Clinical Benefit	Weekly throughout the study	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.
Time to Progression - Number of Participants With an Event	Weekly throughout the study	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.
Time to Progression	Weekly throughout the study	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.
Overall Survival	Weekly throughout the study	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.

Countries

Austria, Germany

Participant flow

Participants by arm

Arm	Count
Trastuzumab Monotherapy Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.	6
Total	6

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Changed to a Different Study	1
Overall Study	Death	1
Overall Study	Disease progression	1
Overall Study	Sponsor decision	1

Baseline characteristics

Characteristic	Trastuzumab Monotherapy
Age, Continuous	62.49 years STANDARD_DEVIATION 9.79
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	6 / 6
serious Total, serious adverse events	3 / 6

Outcome results

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).

Time frame: Weekly throughout study

Population: ITT population

Arm	Measure	Group	Value (NUMBER)
Trastuzumab Monotherapy	Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	CR	0 percentage of participants
Trastuzumab Monotherapy	Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	PR	33.3 percentage of participants
Trastuzumab Monotherapy	Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	SD	0 percentage of participants
Trastuzumab Monotherapy	Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	PD	50.0 percentage of participants
Trastuzumab Monotherapy	Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	Early death from malignant disease	0 percentage of participants
Trastuzumab Monotherapy	Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	Early death because of other cause	16.7 percentage of participants
Trastuzumab Monotherapy	Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category	Unknown	0 percentage of participants

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.