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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165021
First Posted: July 19, 2010
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  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 Drug: Folic Acid Drug: Vitamin B12 Drug: Dexamethasone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] [ Time Frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy ]
    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.


Secondary Outcome Measures:
  • Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)] [ Time Frame: At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy) ]
    pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100.

  • Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0 [ Time Frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy ]
    Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.

  • Overall Survival (OS) [ Time Frame: Enrollment until the date of death from any cause up to 64 months ]
    OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.

  • Progression-Free Survival (PFS) [ Time Frame: Enrollment until the first date of objectively determined PD or death up to 64 months ]
    PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.


Enrollment: 19
Study Start Date: November 2010
Study Completion Date: April 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed + Cisplatin Drug: Pemetrexed
500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Other Names:
  • Alimta
  • LY231514
Drug: Cisplatin
75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
Drug: Folic Acid
Administered orally.
Drug: Vitamin B12
Administered Intramuscular injection.
Drug: Dexamethasone
Administered orally.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (ECOG)
  • No prior therapy for lung cancer
  • Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01165021     History of Changes
Other Study ID Numbers: 13621
H3E-EW-JMIP ( Other Identifier: Eli Lilly and Company )
First Submitted: July 14, 2010
First Posted: July 19, 2010
Results First Submitted: April 23, 2014
Results First Posted: May 21, 2014
Last Update Posted: February 14, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Dexamethasone
Pemetrexed
Folic Acid
Hydroxocobalamin
Vitamin B 12
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists