Study Stopped
Low accrual rate
Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer
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
1 other identifier
interventional
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Jun 2003
Typical duration for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 24, 2003
CompletedFirst Posted
Study publicly available on registry
June 25, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
June 3, 2011
CompletedMay 9, 2016
April 1, 2016
4.8 years
June 24, 2003
August 25, 2010
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Response
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.
5 Years to collect outcome information
Study Arms (2)
Chemotherapy + Tarceva
ACTIVE COMPARATORChemotherapy Alone
ACTIVE COMPARATORInterventions
150 mg/day, starting day 1 and stopping night prior to surgery.
Planned dose of 200 mg/m\^2 continuous IV infusion over 3 hours on Day 1 of each 21-day cycle.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Despite active study recruitment and screening for this study, only 5 subjects were enrolled out of the planned 40 subjects. Of the 5 subjects enrolled, only 1 patient was evaluable for response assessment. The study was subsequently terminated.
Results Point of Contact
- Title
- Mellanie Price, B.S.
- Organization
- University of Texas M.D. Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Zinner, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2003
First Posted
June 25, 2003
Study Start
June 1, 2003
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
May 9, 2016
Results First Posted
June 3, 2011
Record last verified: 2016-04