- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042835
Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer
A Phase I Study Of OSI-774 (NSC #718781)-Based Multimodality Therapy For Inoperable Stage III Non Small Cell Lung Cancer
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of erlotinib that can be administered with chest radiotherapy in combination with cisplatin and etoposide or carboplatin and paclitaxel in patients with inoperable stage III non-small cell lung cancer.
II. Determine the dose-limiting toxicity of these regimens in these patients. III. Assess the clinical response (complete response, partial response, progressive disease, or stable disease) in patients treated with these regimens.
IV. Determine levels of tumor epidermal growth factor expression in patients treated with these regimens.
OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients are assigned to 1 of 2 treatment groups.
GROUP 1: Patients receive cisplatin IV over 2 hours on days 1, 8, 29, and 36; etoposide IV over 1 hour on days 1-5 and 29-33; and oral erlotinib once daily on days 1-49. Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1. Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50, 71, and 92. Some patients may also receive oral erlotinib once daily on days 50-112.
GROUP 2: Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21. Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43, 50, 57, 64, 71, 78, and 85 and oral erlotinib once daily on days 43-91. Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43.
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib during concurrent chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. At least 12 patients from each group are treated at the MTD.
Patients are followed at 8 weeks.
PROJECTED ACCRUAL: A total of 24-48 patients (12-24 per treatment group) will be accrued for this study within 6-12 months.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed non-small cell lung cancer
- Squamous cell carcinoma
- Adenocarcinoma (including bronchoalveolar)
- Large cell carcinoma (including giant and clear cell carcinomas)
- Stage IIIA (T1 or T2, N2) or IIIB disease not amenable to resection or surgery
- T3, N2 or T4, N0-N2 disease also allowed if based on the closeness to the carina, invasion of the mediastinum, or invasion of the chest wall
- T3, N0-N1 disease allowed provided the disease is not amenable for surgical resection
- No M1 disease
No disease invasion of a vertebral body
- Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiotherapy boost field and there is no bone invasion
- Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiotherapy boost field
Pleural effusion that is transudative, cytologically negative, and non-bloody allowed if the tumor can be encompassed in a reasonable field of radiotherapy
- No exudative, bloody, or cytologically malignant effusions
- Effusions present on CT scans but not on chest x-ray (CXR) and too small for thoracentesis are allowed
Measurable or evaluable disease
- Pleural effusions are not considered measurable or evaluable
- Measurable disease is defined as any mass in 2 perpendicular diameters by CXR, CT scan, or MRI
Evaluable disease includes lesions apparent on CXR or CT scan that are:
- Ill-defined masses associated with post-obstructive changes
- Mediastinal or hilar adenopathy measurable in only one dimension
- Performance status - ECOG 0-1
- Performance status - Karnofsky 70-100%
- More than 6 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase normal
- AST and ALT normal and alkaline phosphatase no greater than 2.5 times ULN
- Creatinine normal
- Creatinine clearance at least 50 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of cornea abnormalities (e.g., dry-eye syndrome, Sjögren's syndrome)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose)
- No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
- No gastrointestinal tract disease resulting in the inability to take oral medications
- No required IV alimentation
- No peptic ulcer disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy to compounds of similar chemical or biologic composition to erlotinib or other study agents
- No significant traumatic injury within the past 21 days
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other active malignancy within the past 6 months except non-melanoma skin cancer
- No concurrent colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) with radiotherapy
- No prior chemotherapy for lung cancer
- See Disease Characteristics
- No prior chest radiotherapy
- See Disease Characteristics
- At least 7 days since prior mediastinoscopy
- More than 3 weeks since prior formal exploratory thoracotomy
- More than 3 weeks since prior major surgery
- No prior surgical procedures affecting absorption
- No prior epidermal growth factor receptor-targeting therapies
- No other concurrent investigational or commercial agents or therapies directed at malignancy
- No concurrent combination antiretroviral therapy for HIV-positive patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (cisplatin, etoposide, erlotinib, and docetaxel)
Patients receive cisplatin IV over 2 hours on days 1, 8, 29, and 36; etoposide IV over 1 hour on days 1-5 and 29-33; and oral erlotinib once daily on days 1-49.
Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1.
Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50, 71, and 92.
Some patients may also receive oral erlotinib once daily on days 50-112.
|
Correlative studies
Given IV
Other Names:
Undergo radiotherapy
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given orally
Other Names:
|
Experimental: Group II (paclitaxel, carboplatin, and erlotinib
Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43, 50, 57, 64, 71, 78, and 85 and oral erlotinib once daily on days 43-91.
Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43.
|
Correlative studies
Undergo radiotherapy
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
Time Frame: 7 weeks
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response assessed using RECIST
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
Level of EGFR expression
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ann Mauer, University of Chicago Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Adenocarcinoma of Lung
- Adenocarcinoma, Bronchiolo-Alveolar
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Docetaxel
- Carboplatin
- Etoposide
- Etoposide phosphate
- Paclitaxel
- Erlotinib Hydrochloride
- Cisplatin
Other Study ID Numbers
- NCI-2012-02478
- N01CM62201 (U.S. NIH Grant/Contract)
- N01CM17102 (U.S. NIH Grant/Contract)
- 11432B
- CDR0000069474 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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