Neoadjuvant Chemo for NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Glen Weiss, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01860040
First received: May 17, 2013
Last updated: May 27, 2014
Last verified: May 2014

May 17, 2013
May 27, 2014
April 2013
April 2015   (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 ] [ Designated as safety issue: No ]
Determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)
Same as current
Complete list of historical versions of study NCT01860040 on ClinicalTrials.gov Archive Site
  • Histologic response rate and correlation with disease-free survival (DFS) and overall survival (OS) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assess the CT and/or PET response rate and their respective correlations with DFS and OS
Same as current
Not Provided
Not Provided
 
Neoadjuvant Chemo for NSCLC
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)

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
    Other Name: Platinol®
  • Drug: Pemetrexed
    Other Name: Alimta®
  • Drug: Gemcitabine
    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.
 
Recruiting
44
April 2016
April 2015   (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
Both
18 Years and older
No
Contact: Chari Poteet, RN 623-207-3000 clinicaltrials@ctca-hope.com
Contact: India Hill, CCRP 623-207-3000 clinicaltrials@ctca-hope.com
United States
 
NCT01860040
13-04
No
Glen Weiss, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Not Provided
Western Regional Medical Center
May 2014

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