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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00071136
First received: October 13, 2003
Last updated: January 24, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Lung Neoplasms
Drug: pemetrexed
Drug: gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To measure the effects of chemotherapy treatment on:
  • 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;
  • To measure the side-effects from this chemotherapy as given once every 14 days.

Estimated Enrollment: 48
Study Start Date: December 2003
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Have been treated with an investigational/research drug within the last month.
  2. Have cancer that has spread to the brain and is causing symptoms.
  3. Have an active infection or other serious medical condition.
  4. Have a second cancer in addition to non-small cell lung cancer.
  5. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071136

Locations
United States, Florida
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.
Ft. Myers, Florida, United States
United States, Minnesota
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.
Marshfield, Minnesota, United States
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.
Minneapolis, Minnesota, United States
United States, New York
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.
Rochester, New York, United States
United States, Texas
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.
Dallas, Texas, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00071136     History of Changes
Other Study ID Numbers: 7221, H3E-US-JMGC
Study First Received: October 13, 2003
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gemcitabine
Pemetrexed
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014