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

NCT01443078 | Completed Phase 2 Results

• 1 other identifier: 11-106
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Lung Cancer

Keywords

Carboplatin; Cisplatin; Pemetrexed (Altima); Taxotere (Docetaxel); Vinorelbine Tartrate (Navelbine); Stage IB-III; non squamous; non-small cell lung cancer; 11-106

Outcome Measures

Primary Outcomes (1)

• PERCIST Partial Metabolic Response

  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).

  2 years

Secondary Outcomes (1)

• Pathologic Response Rate

  2 years

Study Arms (1)

pemetrexed plus cisplatin, vinorelbine and docetaxel

EXPERIMENTAL

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.

Drug: pemetrexed; Drug: cisplatin; Drug: Carboplatin; Drug: Gemcitabine Hydrochloride; Drug: Vinorelbine Tartrate; Drug: Docetaxel

Interventions

pemetrexed DRUG

pemetrexed plus cisplatin, vinorelbine and docetaxel

cisplatin DRUG

pemetrexed plus cisplatin, vinorelbine and docetaxel

Carboplatin DRUG

pemetrexed plus cisplatin, vinorelbine and docetaxel

Gemcitabine Hydrochloride DRUG

pemetrexed plus cisplatin, vinorelbine and docetaxel

Vinorelbine Tartrate DRUG

pemetrexed plus cisplatin, vinorelbine and docetaxel

Docetaxel DRUG

pemetrexed plus cisplatin, vinorelbine and docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Eli Lilly and Company: collaborator
• United States Department of Defense: collaborator

Study Sites (5)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Carboplatin; Gemcitabine; Vinorelbine; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Chaft, Jamie, MD
• Organization: Memorial Sloan Kettering Cancer Center

ChaftJ@mskcc.org

646-888-4545

Study Officials

• Jamie E. Chaft, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 29, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 9, 2018
• Results First Posted: August 9, 2016

Record last verified: 2018-07

Locations

US (5)