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

Purpose

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	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: pemetrexed Drug: cisplatin Drug: carboplatin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Cisplatin Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Grade III/IV Adverse Events [ Time Frame: every 21-day cycle for 4 cycles ] [ Designated as safety issue: Yes ]
Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
Overall Survival at 3 Years [ Time Frame: baseline to date of death from any cause, assessed at 3 years ] [ Designated as safety issue: Yes ]
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 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years [ Time Frame: length of time disease free, assessed at 3 years ] [ Designated as safety issue: No ]
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.
Overall Survival at 6 Years [ Time Frame: Baseline to date of death from any cause assessed at 6 years ] [ Designated as safety issue: Yes ]
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.


Enrollment:	122
Study Start Date:	December 2005
Study Completion Date:	July 2013
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 milliliterminute (mg/mlmin), intravenous (IV), every 21 days x 4 cycles

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269152

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
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Rennes, France, 35033
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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
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Köln, Germany, D-51109
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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
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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.
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

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site


Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00269152 History of Changes
Other Study ID Numbers:	10105 H3E-SB-S089
Study First Received:	December 21, 2005
Results First Received:	November 12, 2008
Last Updated:	July 28, 2015
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 29, 2016