Trial of Pemetrexed or Pemetrexed With Gemcitabine for Patients With Advanced Lung Cancer Who Are Not Eligible for Platinum-Based Chemotherapy and Have Not Previously Been Treated With Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00489983
First received: June 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

This study is for elderly patients who haven't been given prior chemotherapy or for patients who cannot be treated with platinum based chemotherapy. The patients who are eligible for this study will have been diagnosed with advanced or metastatic non-small cell lung cancer. The patients will be randomly assigned to one of two treatment options: single agent pemetrexed or single agent pemetrexed with single agent gemcitabine following right after the pemetrexed treatment.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: pemetrexed
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase 2 Randomized Trial of Single-Agent ALIMTA or ALIMTA With Sequentially Administered GEMZAR as First-Line Chemotherapy in Elderly Patients or Patients Who Are Not Eligible for Platinum-Based Chemotherapy With Advanced NSCLC

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To evaluate efficacy.

Secondary Outcome Measures:
  • To evaluate toxicity.
  • To evaluate response.
  • To evaluate overall survival, duration of overall response, and duration of stable disease.

Enrollment: 91
Study Start Date: July 2003
Study Completion Date: March 2005
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically confirmed NSCLC not amenable to surgery or radiotherapy of curative intent
  • locally advanced or metastatic Stage IIIb (with N3 supraclavicular or T4 for pleural effusion) or IV NSCLC
  • no prior chemotherapy
  • measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000)
  • men and women greater than or equal to 70 years of age or patients who, in the investigator’s opinion, are not eligible for platinum-based chemotherapy

Exclusion Criteria:

  • have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  • have symptomatic brain metastases
  • have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
  • are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
  • are unable or unwilling to take steroids
  • are unable or unwilling to take folic acid or vitamin B12 supplementation
  • have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
  • have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:

    • congestive heart failure or angina pectoris, except if it is medically controlled
    • previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
    • active infection requiring iv antibiotics
    • active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
    • superior vena cava syndrome
  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: NCT00489983

Locations
Germany
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.
Berlin, Germany
Italy
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.
Milano, Italy
United Kingdom
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.
London, United Kingdom
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00489983     History of Changes
Other Study ID Numbers: 5119, H3E-EW-JMEM
Study First Received: June 20, 2007
Last Updated: June 20, 2007
Health Authority: Germany: Ethics Commission
Italy: Ministry of Health
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014