A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01165021
First received: July 14, 2010
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Pemetrexed
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Proportion of patients whose response is a complete response (CR) or partial response (PR) [ Time Frame: From study enrollment until disease progression (PD) or recurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with no viable tumor cells in resected lung tissue [ Time Frame: At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 of chemotherapy) ] [ Designated as safety issue: No ]
  • Proportion of patients who exhibit a downward shift in tumor extent from stage IIIAN2 to stage IIIA, II, I, or 0 [ Time Frame: After completion of 3 cycles of chemotherapy ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From study enrollment until the date of death from any cause ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: From study enrollment until the first date of objectively determined Progressive Disease or death from any cause ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: November 2010
Estimated Study Completion Date: March 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed + Cisplatin Drug: Pemetrexed
500 mg/m² administered as an Intravenous infusion on day 1 of 21 day cycle, for 3 cycles
Other Names:
  • Alimta
  • LY231514
Drug: Cisplatin
75 mg/m² administered as an Intravenous infusion on day 1 of 21 day cycle, for 3 cycles

  Eligibility

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

Inclusion Criteria:

  • Nonsquamous Non Small Cell Lung Cancer that was confirmed by tissue biopsy
  • Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
  • Tumor considered potentially resectable
  • Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale)
  • No prior therapy for lung cancer
  • Measurable disease according to version 1.1 of RECIST Criteria
  • Life expectancy of at least 6 months
  • Organs are functioning well (bone marrow reserve, liver, kidney, lung)
  • Signed Informed Consent
  • Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
  • Men must be surgically sterile,or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
  • Be fit for surgery at the time of enrollment

Exclusion Criteria:

  • Receiving or have received an investigational drug or device within the last 30 days
  • Have previously completed or withdrawn from this study or any other study investigating pemetrexed
  • Serious concomitant systemic disorder
  • Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
  • Receiving concurrent administration of any other anticancer therapy
  • Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
  • Inability or unwillingness to take Pemetrexed supplementation/ premedication (folic acid, vitamin B12 , or corticosteroids
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165021

Locations
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Milano, Italy, 20133
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Novara, Italy, 28100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orbassano, Italy, 10043
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Padova, Italy, 35100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pisa, Italy, 56100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rome, Italy, 00144
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sondalo, Italy, 23039
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01165021     History of Changes
Other Study ID Numbers: 13621, H3E-EW-JMIP
Study First Received: July 14, 2010
Last Updated: July 11, 2013
Health Authority: Italy: The Italian Medicines Agency

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
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014