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Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer

This study has been terminated.
(Poor accrual, no data to analyze)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01860040
First Posted: May 22, 2013
Last Update Posted: October 25, 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.
Information provided by (Responsible Party):
Western Regional Medical Center
May 17, 2013
May 22, 2013
April 26, 2016
October 25, 2017
October 25, 2017
April 2013
September 2014   (Final data collection date for primary outcome measure)
Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer [ Time Frame: One year ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions
Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer [ Time Frame: One year ]
Determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)
Complete list of historical versions of study NCT01860040 on ClinicalTrials.gov Archive Site
Not Provided
  • Histologic response rate and correlation with disease-free survival (DFS) and overall survival (OS) [ Time Frame: One year ]
    Assess the histologic response rate and its correlation with DFS and OS
  • Imaging response rate and correlation with DFS and OS [ Time Frame: One year ]
    Assess the CT and/or PET response rate and their respective correlations with DFS and OS
Not Provided
Not Provided
 
Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer
Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer
To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)

Participants in this study will have a lung mass and are undergoing a procedure to determine if they have non-small cell lung cancer that could be removed surgically. If confirmed to have non-small cell lung cancer that can be surgically removed, he or she may be able to continue as a possible participant in this study.

The purpose of this study is to determine whether neoadjuvant chemotherapy (chemotherapy that is given before surgery) will improve the amount of time a participant is free from disease in people with non-metastatic (has not spread from the original site) non-small cell lung cancer. The chemotherapy medications that will be used in this study are cisplatin and pemetrexed or cisplatin and gemcitabine and have been shown to be effective in patients with non-small cell lung cancer.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
  • Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
  • Drug: Cisplatin
    Alkylating antineoplastic agent (Chemotherapy)
    Other Name: Platinol®
  • Drug: Pemetrexed
    Antimetabolite antineoplastic agent (Chemotherapy)
    Other Name: Alimta®
  • Drug: Gemcitabine
    Antimetabolite antineoplastic agent (Chemotherapy)
    Other Name: Gemzar®
  • Experimental: Cisplatin and pemetrexed
    Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
    Interventions:
    • Drug: Cisplatin
    • Drug: Pemetrexed
  • Experimental: Cisplatin and gemcitabine
    Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2016
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients ≥ 18 years of age with either a mass suspicious for or histologically confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of NSCLC, a biopsy will be done and only those patients with histologically confirmed NSCLC meeting all other eligibility criteria may proceed on protocol.
  2. Mass must be determined to be surgically resectable
  3. Eastern Cooperative Oncology Group (ECOG) performance status score < 1 and a life expectancy >3 months.
  4. Participants must have at least one evaluable lesion as defined by RECIST 1.1
  5. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
  6. Serum creatinine ≤1.3 mg/dL (candidate for cisplatin chemotherapy), total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
  7. No prior chemotherapy or radiotherapy for NSCLC
  8. At least 5 years from diagnosis of another cancer except treated in-situ disease or surgically resected non-melanoma skin cancer with clear margins.
  9. Willingness to provide permission to biopsy NSCLC for collection of frozen pretreatment sample.
  10. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial

Exclusion Criteria:

  1. Active clinically serious infection > CTCAE (version 4.03) Grade 2.
  2. Serious non-healing wound, ulcer, or bone fracture.
  3. Major contraindication to surgical resection of NSCLC
  4. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
  5. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
  6. Patients receiving any other investigational agents.
  7. Pregnant or lactating females
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
 
 
NCT01860040
13-04
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Glen Weiss, MD Western Regional Medical Center
Western Regional Medical Center
September 2017

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