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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00269152

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 patients with completely resected, stage Ib or IIa/IIb 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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Cancer 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 ]

Secondary Outcome Measures:

Grade III/IV Adverse Events [ Time Frame: every 21-day cycle for 4 cycles ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: baseline to date of death from any cause, assessed at 3 years ] [ Designated as safety issue: Yes ]
Disease Free Survival [ Time Frame: length of time disease free, assessed at 3 years ] [ Designated as safety issue: No ]

Enrollment:	122
Study Start Date:	December 2005
Estimated Study Completion Date:	July 2010
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: pemetrexed A and B: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles Drug: cisplatin 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
B: Experimental	Drug: pemetrexed A and B: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles Drug: carboplatin area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles

Eligibility

Ages Eligible for Study:	18 Years and older
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 leat 5 years ago.

Contacts and Locations

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.
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.
Toulouse, France, 31059
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Bordeaux, France, 33076
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Rennes, France, 35033
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St Priest En Jarez, France, 42270
Germany
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Loewenstein, Germany, 74245
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Mainz, Germany, D-55131
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Mannheim, Germany, 68167
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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
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.
Kassel, Germany, 34125
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Köln, Germany, D-51109
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.
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
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

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

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10105, H3E-SB-S089
Study First Received:	December 21, 2005
Results First Received:	November 12, 2008
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00269152 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Antimetabolites
Thoracic Neoplasms
Adjuvants, Immunologic
Folate
Carboplatin
Folinic Acid
Folic Acid Antagonists
Vitamin B9
Carcinoma
Folic Acid

Pemetrexed
Respiratory Tract Diseases
Cisplatin
Radiation-Sensitizing Agents
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Carboplatin
Folic Acid Antagonists
Pharmacologic Actions

Carcinoma
Pemetrexed
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009