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:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01165021
First received: July 14, 2010
Last updated: April 10, 2013
Last verified: April 2013
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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 |
| Estimated Primary Completion Date: | June 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:
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: | April 10, 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 May 21, 2013