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Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00363415
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : October 6, 2009
Last Update Posted : October 28, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: pemetrexed Drug: etoposide Drug: carboplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 908 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
Study Start Date : August 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008


Arm Intervention/treatment
Experimental: A Drug: pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Other Names:
  • LY231514
  • Alimta

Drug: carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Active Comparator: B Drug: etoposide
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles

Drug: carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: baseline to date of death from any cause (up to 19.6 months) ]
    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.


Secondary Outcome Measures :
  1. Overall Survival (Subgroups) [ Time Frame: baseline to date of death from any cause (up to 19.6 months) ]
    The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.

  2. Progression Free Survival [ Time Frame: baseline to measured progressive disease (up to 14.7 months) ]
    The period from study entry until disease progression, death or date of last contact.

  3. Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) [ Time Frame: baseline and 6 cycles (21-day cycles) ]
    FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.

  4. Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) [ Time Frame: baseline to date of death due to any cause (up to 19.6 months) ]
    The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
  • Capable of self-care but may be unable to carry out any work activities.
  • No prior anticancer therapy for SCLC

Exclusion Criteria:

  • have previously participated in a study involving pemetrexed
  • have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363415


Locations
Show Show 190 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00363415    
Other Study ID Numbers: 9691
H3E-MC-JMHO
First Posted: August 15, 2006    Key Record Dates
Results First Posted: October 6, 2009
Last Update Posted: October 28, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Pemetrexed
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors