Status:
COMPLETED
Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Eli Lilly and Company
United States Department of Defense
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach...
Eligibility Criteria
Inclusion
- Pathologic confirmation of NSCLC at MSKCC
- Stages IB, IIA, IIB, IIIA or IIIB NSCLC
- Primary tumor must measure ≥ 2 cm on CT imaging (per PERCIST guidelines)
- Primary tumor must be FDG-avid with an SUVmax \>4.5 (to be consistent with PERCIST guidelines)
- Patients must be candidates for resection with curative intent
- Age ≥ 18 years
- Karnofsky performance status ≥ 70%
- Normal bone marrow function
- leukocytes ≥ 3,000/μl
- absolute neutrophil count ≥ 1,500/μl
- platelets ≥100,000/μl
- hemoglobin ≥9gm/dl.
- Adequate hepatic function
- Total bilirubin ≤1.5 x ULN
- AST ≤ 1.5 x UNL, ALT ≤ 1.5 x ULN
- Alkaline phosphatase ≤ 1.5x ULN
- Women of childbearing age must have a negative pregnancy test
- Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion
- Patients must not be receiving any other investigational agents
- History of myocardial infarction or unstable angina within the past 12 months Patients with peripheral neuropathy \> grade 1
- Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection.
- Patients with diabetes mellitus requiring insulin therapy (per PERCIST guidelines)
- Patients with third space fluid which cannot be adequately controlled with drainage
- Women who are pregnant or breast-feeding
- Psychiatric illness or social situation that would limit compliance with study requirements
- Patients with known HIV infection requiring antiretroviral medications and those with AIDS
- Baseline subjective hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily living (CTCAE grade 2 or higher)
- Baseline renal function \<60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
- Congestive heart failure with New York Heart Association functional classification \> II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.
- Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all of the following criteria:
- Non-squamous histology
- Patients must have the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
- Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol
- Patient refuses to take cisplatin
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01443078
Start Date
October 1 2011
End Date
April 1 2015
Last Update
August 9 2018
Active Locations (5)
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1
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States