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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00269152
First received: December 21, 2005
Last updated: July 15, 2014
Last verified: July 2014
  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:


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 milliliter*minute (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 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
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
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
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
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
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
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.
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

Additional Information:
No publications provided

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 15, 2014
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
Pemetrexed
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 30, 2014