NCT Number: NCT01443078
Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
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 has on the cancer.
It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery.
In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
Cisplatin
Drugcarboplatin
Druggemcitabine hydrochloride
DrugVinorelbine Tartrate
Drugdocetaxel
DrugPrimary outcomes
-
PERCIST Partial Metabolic Response
Time frame: 2 years
The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline).
Secondary outcomes
-
Pathologic Response Rate
Time frame: 2 years
The percentage of patients with a major pathologic response
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- Eli Lilly and Company
- United States Department of Defense
Registry information
Official study title
Phase II Trial of Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
Important dates
- Study start
- 2011
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 29, 2011
- Registry last updated
- Aug 9, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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