Erlotinib in Treating Patients With Early-Stage Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00087269

Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: erlotinib hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study To Evaluate The Tumor Biochemical Effects Of The EGFR Tyrosine Kinase Inhibitor OSI-774 (Erlotinib) Administered Prior To Surgical Resection In Patients With Early Stage Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Biochemical response rate (i.e., > 75% decrease in MAP kinase protein and/or AKT-1 protein) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Designated as safety issue: Yes ]

Study Start Date:

December 2004

Detailed Description:

OBJECTIVES:

Primary

Determine the biochemical response rate, in terms of a decrease of more than 75% in MAP kinase protein and/or AKT-1 protein, in patients with early-stage operable non-small cell lung cancer treated with neoadjuvant erlotinib.

Secondary

Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity.

Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21).

Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician.

Patients are followed for 5 years after study registration.

PROJECTED ACCRUAL: A total of 55-110 patients will be accrued for this study within 11-22 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Meets 1 of the following stage criteria:
  - Stage IA (T1, N0, M0)
  - Stage IB (T2, N0, M0)
  - Stage IIA (T1, N1, M0)
  - Stage IIB (T2, N1, M0 or T3, N0-1, M0)
  - Stage IIIA (T1-3, N2, M0)
Surgical candidate with resectable disease
No small-cell component
Paraffin-embedded cell block and 1-2 segments of frozen tissue demonstrating NSCLC available

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
WBC ≥ 3,500/mm^3

Hepatic

SGPT and SGOT < 3 times upper limit of normal
Bilirubin < 1.5 mg/dL

Renal

Creatinine < 2 mg/dL OR
Creatinine clearance ≥ 20 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Able to take oral medication
No malabsorption syndrome
No known hypersensitivity to erlotinib
No serious underlying medical condition that would preclude study participation
No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent myeloid growth factors

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics
No prior gastrointestinal surgery that would limit absorption (i.e., requires total parental nutrition)

Other

At least 2 weeks since prior CYP3A4 enzyme-inducing agents
More than 21 days since prior investigational drugs
No prior anti-epidermal growth factor receptor therapy
No concurrent anticoagulation therapy
No concurrent CYP3A4 enzyme-inducing agents, including the following:
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Oxcarbazepine
- Rifapentine
- Hypericum perforatum (St. John's wort)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087269

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Steven M. Keller, MD	Montefiore Medical Center
Investigator:	Roman Perez-Soler, MD	Montefiore Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000373871, ECOG-E4503
Study First Received:	July 8, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00087269 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010