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Completed

NCT Number: NCT00061451

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

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 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Palo Alto, California, 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  • Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.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 4 weeks.
  • Brain metastasis that is uncontrolled.
  • Active infection or other serious condition.

Treatment and study plan

Pemetrexed

Drug

Gemcitabine

Drug

Primary outcomes

  1. To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.

Secondary outcomes

  1. To assess time to objective tumor response for responding patients

  2. To assess duration of response for responding patients

  3. To assess time to treatment failure for patients

  4. To assess progression free survival of patients

  5. To assess time to progressive disease for patients

  6. To assess survival time for patients

  7. To characterize the toxicities of gemcitabine plus pemetrexed in this patient population

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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
2002
Study completion
2006
First posted
May 29, 2003
Registry last updated
Dec 22, 2010

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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