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Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01443078
First Posted: September 29, 2011
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eli Lilly and Company
United States Department of Defense
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
September 26, 2011
September 29, 2011
June 29, 2016
August 9, 2016
October 6, 2017
October 2011
April 2015   (Final data collection date for primary outcome measure)
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).
response rate by FDG PET [ Time Frame: 2 years ]
(complete metabolic response + partial metabolic response) to alternative, non-platinum chemotherapy (vinorelbine + docetaxel) in patients with resectable Stage Ib-IIIa "non-squamous", NSCLC who do not respond to 2 cycles of pemetrexed + cisplatin. The baseline for comparison for the primary endpoint is the PET scan performed immediately before the alternative chemotherapy.
Complete list of historical versions of study NCT01443078 on ClinicalTrials.gov Archive Site
Overall Response Rate [ Time Frame: 2 years ]
(FDG PET and CT), rate of pathologic down-staging, rate of pathologic response, and stage-specific disease free and overall survival in patients with resectable Stage Ib-IIIa "non-squamous", NSCLC treated with neoadjuvant pemetrexed + cisplatin
  • Overall Response Rate [ Time Frame: 2 years ]
    (FDG PET and CT), rate of pathologic down-staging, rate of pathologic response, and stage-specific disease free and overall survival in patients with resectable Stage Ib-IIIa "non-squamous", NSCLC treated with neoadjuvant pemetrexed + cisplatin
  • overall survival [ Time Frame: 2 years ]
    DFS and OS will be calculated among patients evaluable for the primary objective. Followup for OS will start, at the time patients receive the first dose of vinorelbine + docetaxel, while for DFS it will start at the time of surgery.
  • Evaluate the prognostic significance of radiographic response [ Time Frame: 2 years ]
    The sample size calculation is based on the ability to determine the objective response rate (CMR + PMR) to non-platinum chemotherapy (vinorelbine + docetaxel) in patients with resectable Stage IB-IIIA "non-squamous", NSCLC who do not respond to 2 cycles of pemetrexed + platinum (<35% change in SUVpeak on FDG PET by modified PERCIST criteria).
  • Determine the safety and tolerability [ Time Frame: 2 years ]
    Safety and tolerability will be determined separately for the two neoadjuvant treatment regimens: pemetrexed + platinum and vinorelbine + docetaxel. Toxicity data (AEs, laboratory data and vital sign data) will be collected, tabulated according to CTCAE version 3.0 and summarized using descriptive statistics.
Not Provided
Not Provided
 
Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
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)

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • Drug: pemetrexed
  • Drug: cisplatin
  • Drug: Carboplatin
  • Drug: Gemcitabine Hydrochloride
  • Drug: Vinorelbine Tartrate
  • Drug: Docetaxel
Experimental: pemetrexed plus cisplatin, vinorelbine and docetaxel
This is a phase 2 clinical trial for patients with clinical Stage IB-III resectable and operable non-small cell lung cancer, evaluating whether the switch to an alternative, non-platinum neoadjuvant chemotherapy is safe and effective in patients who do not respond to neoadjuvant platinum-based chemotherapy. Those who fail to respond to platinum-based chemotherapy will be switched to the alternative neoadjuvant chemotherapy vinorelbine 45 mg/m2 and docetaxel 45 mg/m2 on day 1 followed by pegylated filgrastim on day 2, repeated every 2 weeks for 4 doses, followed by repeat FDG PET and CT scan.
Interventions:
  • Drug: pemetrexed
  • Drug: cisplatin
  • Drug: Carboplatin
  • Drug: Gemcitabine Hydrochloride
  • Drug: Vinorelbine Tartrate
  • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01443078
11-106
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • Eli Lilly and Company
  • United States Department of Defense
Principal Investigator: Jamie E. Chaft, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP