Back to results

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

Primary Purpose

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

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cisplatin

Pemetrexed

Gemcitabine

About this trial

This is an interventional treatment trial for Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Western Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cisplatin and pemetrexed

Cisplatin and gemcitabine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01860040

First Posted

May 17, 2013

Last Updated

January 11, 2018

Sponsor

Western Regional Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01860040

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual, no data to analyze

Study Start Date

April 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Western Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin and pemetrexed

Arm Type

Experimental

Arm Description

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

Arm Title

Cisplatin and gemcitabine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol®

Intervention Description

Alkylating antineoplastic agent (Chemotherapy)

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta®

Intervention Description

Antimetabolite antineoplastic agent (Chemotherapy)

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar®

Intervention Description

Antimetabolite antineoplastic agent (Chemotherapy)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glen Weiss, MD

Organizational Affiliation

Western Regional Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Western Regional Medical Center

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85338

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs