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

• ClinicalTrials.gov Identifier: NCT00489983
• Recruitment Status: Completed
• First Posted: June 22, 2007
• Last Update Posted: June 22, 2007
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: pemetrexed; Drug: gemcitabine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: July 2003
• Actual Study Completion Date: March 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. To evaluate efficacy.

Secondary Outcome Measures :

1. To evaluate toxicity.
2. To evaluate response.
3. To evaluate overall survival, duration of overall response, and duration of stable disease.

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Lilly Clinical Trial Registry 

• ClinicalTrials.gov Identifier: NCT00489983
• Other Study ID Numbers: 5119; H3E-EW-JMEM
• First Posted: June 22, 2007
• Last Update Posted: June 22, 2007
• Last Verified: June 2007

Additional relevant MeSH terms:

Lung 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; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors