Trial record 3 of 38 for:    western regional weiss | Open Studies

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
  Purpose

To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)


Condition Intervention Phase
Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
Drug: Cisplatin
Drug: Pemetrexed
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin and pemetrexed
Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Drug: Cisplatin
Other Name: Platinol®
Drug: Pemetrexed
Other Name: Alimta®
Experimental: Cisplatin and gemcitabine
Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Drug: Cisplatin
Other Name: Platinol®
Drug: Gemcitabine
Other Name: Gemzar®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860040

Contacts
Contact: Chari Poteet, RN 623-207-3000 clinicaltrials@ctca-hope.com
Contact: India Hill, CCRP 623-207-3000 clinicaltrials@ctca-hope.com

Locations
United States, Arizona
Western Regional Medical Center Recruiting
Goodyear, Arizona, United States, 85338
Principal Investigator: Glen J Weiss, MD         
Sponsors and Collaborators
Western Regional Medical Center
  More Information

No publications provided

Responsible Party: Glen Weiss, MD, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01860040     History of Changes
Other Study ID Numbers: 13-04
Study First Received: May 17, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 01, 2014