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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004883
• Other study ID #: NCI-2012-02318
• Secondary ID: CLB-39810U10CA03
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: January 15, 2013
• Start date: February 2000

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Intervention

Biological:
• trastuzumab
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (complete response [CR] and partial response [PR])		Up to 5 years	No
Secondary	Overall survival (OS)	Kaplan-Meier curves will be used to describe OS.	From registration until death or last known follow-up, assessed up to 5 years	No
Secondary	Failure-free survival (FFS)	Kaplan-Meier curves will be used to describe FFS.	Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years	No
Secondary	Duration of response	Kaplan-Meier curves will be used to describe duration of response.	Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years	No
Secondary	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.	Up to 5 years	Yes
Secondary	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.	Up to 5 years	No