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NCT Number: NCT00363415

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

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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., Bahía Blanca, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

500 mg/m2, intravenous (IV), every 21 days x 6 cycles

Other names: LY231514, Alimta

etoposide

Drug

100 mg/m2, intravenous (IV), days 1-3 x 6 cycles

carboplatin

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 15, 2006
Registry last updated
Oct 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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