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OpenTrials
Completed

NCT Number: NCT00061464

Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

The purposes of this study are to determine:

1. The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2. Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer. 3. Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4. To see if patients feel better while taking pemetrexed plus Gemcitabine.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy
  • Have received no prior chemotherapy for Non-Small Cell Lung Cancer
  • Have at least one measurable lesion
  • Have an adequate performance status
  • Sign an informed consent

Exclusion criteria

  • A female who is pregnant or breastfeeding
  • Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed
  • Treatment with radiation therapy within the last 1-2 weeks
  • Brain metastasis that is uncontrolled
  • Active infection or other serious condition

Treatment and study plan

Pemetrexed

Drug

Gemcitabine

Drug

Primary outcomes

  1. To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).

Secondary outcomes

  1. To measure time-to-event efficacy variables including:

  2. time to objective tumor response for responding patients

  3. duration of response for responding patients

  4. time to treatment failure

  5. time to progressive disease

  6. progression-free survival

  7. overall survival

  8. To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase II Clinical Trial

Important dates

Study start
2003
Study completion
2006
First posted
May 29, 2003
Registry last updated
Jan 26, 2007

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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