- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269152
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer
This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).
A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bordeaux, France, 33076
- 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.
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Paris, France, 75571
- 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.
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Rennes, France, 35033
- 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.
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St Priest En Jarez, France, 42270
- 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.
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Toulouse, France, 31059
- 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.
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Bad Berka, Germany, 99437
- 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.
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Bielefeld, Germany, D-33604
- 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.
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Großhansdorf, Germany, D-22927
- 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.
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Halle, Germany, D-06120
- 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.
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Hannover, Germany, D-30625
- 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.
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Kassel, Germany, 34125
- 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.
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Köln, Germany, D-51109
- 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.
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Loewenstein, Germany, 74245
- 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.
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Mainz, Germany, D-55131
- 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.
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Mannheim, Germany, 68167
- 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.
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Barcelona, Spain, 08036
- 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.
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Madrid, Spain, 28046
- 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.
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Santiago De Compostela, Spain, 15706
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
- Must have complete tumor resection by pneumonectomy or lobectomy
- Must have been surgically proven to be N2 negative
Exclusion Criteria:
- Serious concomitant systemic disorder
- Post-operative complications or other surgery related conditions
- A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A: Pemetrexed + Cisplatin
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500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles
Other Names:
75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
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Experimental: B: Pemetrexed + Carboplatin
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500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles
Other Names:
area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Feasibility of Post-Surgery Chemotherapy
Time Frame: every 21-day cycle for 4 cycles up to 30 days after last infusion
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Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.
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every 21-day cycle for 4 cycles up to 30 days after last infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Grade III/IV Adverse Events
Time Frame: every 21-day cycle for 4 cycles
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Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
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every 21-day cycle for 4 cycles
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Overall Survival at 3 Years
Time Frame: baseline to date of death from any cause, assessed at 3 years
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For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate.
Results are presented as probability (%) of survival at 3 years.
Overall survival is the duration from enrollment to death.
For participants not known to have died, overall survival was censored at the last known alive date.
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baseline to date of death from any cause, assessed at 3 years
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3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years
Time Frame: length of time disease free, assessed at 3 years
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For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate.
Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause.
For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status.
Results are presented as probability (%) of disease-free survival at 3 years.
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length of time disease free, assessed at 3 years
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Overall Survival at 6 Years
Time Frame: Baseline to date of death from any cause assessed at 6 years
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For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate.
Results are presented as probability (%) of survival at 6 years.
Overall survival is the duration from enrollment to death.
For participants not known to have died, overall survival was censored at the last known alive date.
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Baseline to date of death from any cause assessed at 6 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Carboplatin
- Pemetrexed
Other Study ID Numbers
- 10105 (DAIDS ES)
- H3E-SB-S089 (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on pemetrexed
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Boehringer IngelheimTerminatedCarcinoma, Non-Small-Cell LungJapan
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Shanghai Shengdi Pharmaceutical Co., LtdNot yet recruitingNon-squamous Non-small Cell Lung CancerChina
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Rongjie TaoNational Natural Science Foundation of ChinaUnknown
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Northwestern UniversityNational Cancer Institute (NCI)UnknownLymphoma | Brain and Central Nervous System Tumors | Metastatic CancerUnited States
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PfizerTerminatedCarcinoma, Non-Small Cell LungUnited States, Germany, Italy
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Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedCarcinoma, Non-small-cell LungNorway
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Ain Shams UniversityUnknown
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GlaxoSmithKlineCompletedLung Cancer, Non-Small CellDenmark, United Kingdom
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Eli Lilly and CompanyCompletedNon-Small Cell Lung Cancer Metastatic | Nonsquamous Non-Small Cell Neoplasm of Lung | Non-Small Cell Lung Cancer Stage IIIBUnited Kingdom, Sweden
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University Hospital, AntwerpEli Lilly and Company; Universiteit AntwerpenCompleted