Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: pemetrexed; Drug: cisplatin; Drug: carboplatin	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	122 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	December 2005
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	July 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A: Pemetrexed + Cisplatin	Drug: pemetrexed; 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles; Other Names: LY231514; Alimta Drug: cisplatin; 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
Experimental: B: Pemetrexed + Carboplatin	Drug: pemetrexed; 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles; Other Names: LY231514; Alimta Drug: carboplatin; area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles

Outcome Measures

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Primary Outcome Measures :

1. The Feasibility of Post-Surgery Chemotherapy [ Time Frame: every 21-day cycle for 4 cycles up to 30 days after last infusion ]
   Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.

Secondary Outcome Measures :

1. Grade III/IV Adverse Events [ Time Frame: every 21-day cycle for 4 cycles ]
   Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
2. Overall Survival at 3 Years [ Time Frame: baseline to date of death from any cause, assessed at 3 years ]
   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.
3. 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years [ Time Frame: length of time disease free, assessed at 3 years ]
   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.
4. Overall Survival at 6 Years [ Time Frame: Baseline to date of death from any cause assessed at 6 years ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

France
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.
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.
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.
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.
St Priest En Jarez, France, 42270
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Toulouse, France, 31059
Germany
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Bad Berka, Germany, 99437
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Bielefeld, Germany, D-33604
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Großhansdorf, Germany, D-22927
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Halle, Germany, D-06120
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Hannover, Germany, D-30625
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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.
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.
Loewenstein, Germany, 74245
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Mainz, Germany, D-55131
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Mannheim, Germany, 68167
Spain
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.
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.
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.
Santiago De Compostela, Spain, 15706

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Chair:	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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly Clinical Trial Registry 

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00269152 History of Changes
Other Study ID Numbers:	10105; H3E-SB-S089 ( Other Identifier: Eli Lilly and Company )
First Posted:	December 23, 2005
Results First Posted:	June 11, 2009
Last Update Posted:	August 18, 2015
Last Verified:	July 2015

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; Carboplatin; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors