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Completed

NCT Number: NCT00071136

Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.

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Key information

Conditions

Lung Neoplasms Lung Diseases 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 1 / 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., Fort Myers, 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

  • Have a diagnosis of advanced stage non-small cell lung cancer.
  • Are able to be active at home and/or work.
  • Have not received chemotherapy for this cancer disease.
  • Have good organ function (for example, most blood work is normal).
  • Have completed any prior radiation treatment at least 4 weeks ago.

Exclusion criteria

  • Have been treated with an investigational/research drug within the last month.
  • Have cancer that has spread to the brain and is causing symptoms.
  • Have an active infection or other serious medical condition.
  • Have a second cancer in addition to non-small cell lung cancer.
  • Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.

Treatment and study plan

Pemetrexed

Drug

Gemcitabine

Drug

Primary outcomes

  1. To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases.

Secondary outcomes

  1. To measure the effects of chemotherapy treatment on:

  2. time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive;

  3. To measure the side-effects from this chemotherapy as given once every 14 days.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer

Important dates

Study start
2003
Study completion
2006
First posted
Oct 16, 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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