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

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ClinicalTrials.gov Identifier: NCT02005484
Recruitment Status : Terminated (Study terminated due to slow patient recruitment.)
First Posted : December 9, 2013
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Trastuzumab

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 Name: Herceptin




Primary Outcome Measures :
  1. Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category [ Time Frame: 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 Outcome Measures :
  1. Percentage of Participants With Clinical Benefit [ Time Frame: 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.

  2. Percentage of Participants With a Best Overall Response of CR or PR [ Time Frame: 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.

  3. Overall Survival - Number of Participants Who Died [ Time Frame: 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.

  4. Overall Survival [ Time Frame: 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.

  5. Time to Progression - Number of Participants With an Event [ Time Frame: 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.

  6. Time to Progression [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005484


Locations
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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, 81377
München, Germany, 81675
Oldenburg, Germany, 26133
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02005484     History of Changes
Other Study ID Numbers: ML17263
First Posted: December 9, 2013    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Stomach Neoplasms
Disease Progression
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Disease Attributes
Pathologic Processes
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents