Status:
COMPLETED
Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or c...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated wit...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features meeting 1 of the following stage criteria:
- Stage IIIB disease (with pleural or pericardial effusion)
- Stage IV disease
- Recurrent disease
- Measurable disease
- Tumor tissue available from biopsy
- Age of 18 and over
- ECOG performance status of 0-2
- Life expectancy greater than 3 months
- White blood cell (WBC) ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal
- Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times upper limit of normal
- Creatinine normal OR Creatinine clearance ≥ 60 mL/min
- No more than 1 prior chemotherapy regimen for advanced BAC
- More than 3 years since prior chemotherapy for other malignancies
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for this malignancy and recovered
- HIV-positive patients are eligible provided the following criteria are met:
- CD4 count ≥ 100/mm\^3
- Undetectable viral load within the past 3 months
- Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry
- Fertile patients must use effective contraception
- At least 2 weeks since prior radiotherapy and recovered
- EXCLUSION CRITERIA:
- Untreated brain metastases
- Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy to the brain are eligible
- Acute hepatitis
- Symptomatic congestive heart failure
- Uncontrolled hypertension
- Unstable angina pectoris
- Cardiac arrhythmia
- Pregnant or nursing
- Prior allergic reaction to chimerized or murine monoclonal antibody therapy
- Documented presence of human anti-mouse antibodies
- Ongoing or active infection
- Psychiatric illness or social situation that would preclude study compliance
- Other uncontrolled illness
- Prior cetuximab
- Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib)
- Other concurrent investigational agents
- Other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
October 13 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00103207
Start Date
October 13 2005
End Date
August 1 2012
Last Update
June 28 2023
Active Locations (157)
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1
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
2
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
3
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
4
Porter Adventist Hospital
Denver, Colorado, United States, 80210