Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00063258

Purpose

The goal of this clinical research study is to learn about the safety and effectiveness of OSI-774 when combined with standard chemotherapy (carboplatin and paclitaxel) before surgery in the treatment of non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: Tarceva (OSI-774) Drug: Paclitaxel Drug: Carboplatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Randomized Open-Label Trial of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Tarceva™) in Combination With Paclitaxel and Carboplatin Prior to Surgery in Resectable Stage IIIA (N2) and IIIB (T4 N2) NSCLC: A Clinical Outcome and Biological Endpoint Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients With Response [ Time Frame: 5 Years to collect outcome information ] [ Designated as safety issue: No ]
Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.

Enrollment:	5
Study Start Date:	June 2003
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Chemotherapy + Tarceva	Drug: Tarceva (OSI-774) 150 mg/day, starting day 1 and stopping night prior to surgery. Other Name: Tarceva Drug: Paclitaxel Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle. Other Name: Taxol Drug: Carboplatin Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.
Active Comparator: Chemotherapy Alone	Drug: Paclitaxel Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle. Other Name: Taxol Drug: Carboplatin Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.

Arms

Assigned Interventions

Active Comparator: Chemotherapy + Tarceva

Drug: Tarceva (OSI-774)

150 mg/day, starting day 1 and stopping night prior to surgery.

Other Name: Tarceva

Drug: Paclitaxel

Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.

Other Name: Taxol

Drug: Carboplatin

Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.

Active Comparator: Chemotherapy Alone

Drug: Paclitaxel

Planned dose of 200 mg/m^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.

Other Name: Taxol

Drug: Carboplatin

Dose of AUC = 6 mg/ml × min began within 60 minutes following completion of paclitaxel infusion, infused over 15-30 minutes on Day 1 of Cycle 1 of each 21-day cycle, and then on Day 1 of each subsequent cycle according to institutional standards.

Detailed Description:

This is a phase II, single institution open label randomized trial of induction carboplatin and paclitaxel plus/minus daily oral OSI-774 in patients with potentially resectable NSCLC that is stage IIIA and IIIB (T4 satellite nodules or invasion into T4 structures but no malignant effusion.) N3 disease is excluded. Patients will be required to have pathologically demonstrated N2 disease via mediastinoscopy. Forty patients will be treated with 3 courses of chemotherapy followed by surgery. Ten of these patients will be randomized to chemotherapy alone and 30 patients to chemotherapy plus OSI-774. The 10 patients will serve as a chemotherapy alone control for molecular endpoint analysis. OSI-774 will be stopped the night before surgery. At the time of surgery, pathologic response will be determined. Following surgery, patients will be treated with consolidation radiation therapy if there are positive margins or N2 lymph nodes at the time of resection. Patients who have no N2 disease at surgery will have the option of consolidation radiation therapy but will not be required to have it done. Patients not able to tolerate radiation even if they have N2 disease or positive margins at surgery may continue on this study. This will be followed by maintenance OSI-774 for patients from both arms of the study. OSI-774 will be continued as maintenance to a maximum of 2 years following surgery. Tissue for molecular studies will be obtained pretreatment either at the time of diagnostic biopsy or mediastinoscopy. Post-treatment tissue will be obtained at the time of surgery. This tissue will be assayed for defined molecular endpoints using immunohistochemistry, immunoprecipitation and mRNA expression analysis. Blood, urine, hair follicles, and skin samples will also be collected from patients who consent to provide these.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have signed consent for LAB03-0383
Pathologic documentation of NSCLC
Stage IIIA and IIIB (T4 satellite nodules or invasion into T4 structures but no malignant effusion) with all patients requiring mediastinoscopy positive N2, potentially resectable disease. N3 disease is excluded.
Measurable disease
Zubrod performance status of 0 or 1
Calculated post-resectional FEV1 of > 40%
WBC>4000/l, ANC>1500/l, platelets > 100,000/l
Serum creatinine < 1.5 ULN or calculated creatinine > 50 cc/min
Total serum bilirubin <1.5 x ULN or SGPT or SGOT < 2 X ULN
The following must be completed within 28 days of registration: CT scan of the chest and upper abdomen to include the adrenals. Mediastinoscopy to document ipsilateral nodal involvement and exclude N3 disease Blood tests, and pulmonary function tests The following must be completed within 2 months of registration: Pet scan If a CT PET is done more than 28 days, only the CT needs to be repeated and a bone scan to rule out bone metastases

Exclusion Criteria:

No prior chemotherapy or radiation for NSCLC
No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least five years. If patient is suspected or known to have basal or squamous skin cancer, this maybe treated after induction chemotherapy is completed at the time of thoracotomy.
No post-obstructive pneumonia or other serious infection or other serious underlying medical condition that would impair ability of patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor.
Pregnant or nursing women may not participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063258

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Ralph Zinner, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ralph Zinner, M.D./Assistant Professor, University of Texas M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00063258 History of Changes
Other Study ID Numbers:	ID02-327
Study First Received:	June 24, 2003
Results First Received:	August 25, 2010
Last Updated:	May 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Non-Small Cell Lung Cancer
Lung Cancer
OSI-774
Tarceva

Carboplatin
Paclitaxel
NSCLC

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel

Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012