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

NCT01860040 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 13-04
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer; Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer

  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

  One year

Study Arms (2)

Cisplatin and pemetrexed

EXPERIMENTAL

Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles

Drug: Cisplatin; Drug: Pemetrexed

Cisplatin and gemcitabine

EXPERIMENTAL

Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles

Drug: Cisplatin; Drug: Gemcitabine

Interventions

Cisplatin DRUG

Alkylating antineoplastic agent (Chemotherapy)

Also known as: Platinol®

Cisplatin and gemcitabine; Cisplatin and pemetrexed

Pemetrexed DRUG

Antimetabolite antineoplastic agent (Chemotherapy)

Also known as: Alimta®

Cisplatin and pemetrexed

Gemcitabine DRUG

Antimetabolite antineoplastic agent (Chemotherapy)

Also known as: Gemzar®

Cisplatin and gemcitabine

Eligibility Criteria

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

You may qualify if:

• 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.
• Mass must be determined to be surgically resectable
• Eastern Cooperative Oncology Group (ECOG) performance status score \< 1 and a life expectancy \>3 months.
• Participants must have at least one evaluable lesion as defined by RECIST 1.1
• Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
• 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
• No prior chemotherapy or radiotherapy for NSCLC
• At least 5 years from diagnosis of another cancer except treated in-situ disease or surgically resected non-melanoma skin cancer with clear margins.
• Willingness to provide permission to biopsy NSCLC for collection of frozen pretreatment sample.
• 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

You may not qualify if:

• Active clinically serious infection \> CTCAE (version 4.03) Grade 2.
• Serious non-healing wound, ulcer, or bone fracture.
• Major contraindication to surgical resection of NSCLC
• Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
• Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
• Patients receiving any other investigational agents.
• Pregnant or lactating females

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Interventions

Cisplatin; Pemetrexed; Gemcitabine

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Western Regional Medical Center

jessica.coats@ctca-hope.com

6232073000

Study Officials

• Glen Weiss, MD

  Western Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 22, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: April 1, 2016
• Last Updated: February 7, 2018
• Results First Posted: October 25, 2017

Record last verified: 2018-01

Locations

US (1)