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Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trastuzumab
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed stage IIIB or IV non-small cell lung cancer Supraclavicular node involvement allowed Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative) No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy Recurrent disease allowed HER2 overexpression (2-3+) At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions No CNS metastases Performance status - ECOG 0-2 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN LVEF at least 45% (by echocardiogram or MUGA) Not pregnant or nursing Fertile patients must use effective contraception HIV negative No concurrent immunologic disease (e.g., autoimmune disease) No history of allergy to murine products No prior murine antibodies No prior anthracyclines No more than 1 prior chemotherapy regimen for lung cancer At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) At least 6 months since prior radiotherapy No concurrent palliative radiotherapy At least 4 weeks since prior major surgery

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (trastuzumab)

Arm Description

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Response rate (complete response [CR] and partial response [PR])

Secondary Outcome Measures

Overall survival (OS)
Kaplan-Meier curves will be used to describe OS.
Failure-free survival (FFS)
Kaplan-Meier curves will be used to describe FFS.
Duration of response
Kaplan-Meier curves will be used to describe duration of response.
Toxicity as assessed by NCI's Common Toxicity Criteria
The frequency of occurrence of various toxicities will be tabulated by the most severe occurrence experienced by each individual patient.
Relationship between HER2 expression in tumor tissue and serum
A 95% confidence interval for this proportion will be estimated using the binomial distribution. The level of circulating HER2 receptor will be descriptively summarized with means, medians, quartiles, etc.

Full Information

First Posted
March 7, 2000
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004883
Brief Title
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
Official Title
A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed Description
PRIMARY OBJECTIVES: I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer. SECONDARY OBJECTIVES: I. Determine the duration of response in patients treated with this regimen. II. Determine the toxicity of this treatment regimen in this patient population. III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population. V. Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression. OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression or death. PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (trastuzumab)
Arm Type
Experimental
Arm Description
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
trastuzumab
Other Intervention Name(s)
anti-c-erB-2, Herceptin, MOAB HER2
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate (complete response [CR] and partial response [PR])
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Kaplan-Meier curves will be used to describe OS.
Time Frame
From registration until death or last known follow-up, assessed up to 5 years
Title
Failure-free survival (FFS)
Description
Kaplan-Meier curves will be used to describe FFS.
Time Frame
Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years
Title
Duration of response
Description
Kaplan-Meier curves will be used to describe duration of response.
Time Frame
Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years
Title
Toxicity as assessed by NCI's Common Toxicity Criteria
Description
The frequency of occurrence of various toxicities will be tabulated by the most severe occurrence experienced by each individual patient.
Time Frame
Up to 5 years
Title
Relationship between HER2 expression in tumor tissue and serum
Description
A 95% confidence interval for this proportion will be estimated using the binomial distribution. The level of circulating HER2 receptor will be descriptively summarized with means, medians, quartiles, etc.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed stage IIIB or IV non-small cell lung cancer Supraclavicular node involvement allowed Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative) No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy Recurrent disease allowed HER2 overexpression (2-3+) At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions No CNS metastases Performance status - ECOG 0-2 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN LVEF at least 45% (by echocardiogram or MUGA) Not pregnant or nursing Fertile patients must use effective contraception HIV negative No concurrent immunologic disease (e.g., autoimmune disease) No history of allergy to murine products No prior murine antibodies No prior anthracyclines No more than 1 prior chemotherapy regimen for lung cancer At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) At least 6 months since prior radiotherapy No concurrent palliative radiotherapy At least 4 weeks since prior major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Clamon
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

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Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

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