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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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pemetrexed
gemcitabine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 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.
  • 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.
  • 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.

Outcomes

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.

Full Information

First Posted
June 20, 2007
Last Updated
June 20, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00489983
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Primary Outcome Measure Information:
Title
To evaluate efficacy.
Secondary Outcome Measure Information:
Title
To evaluate toxicity.
Title
To evaluate response.
Title
To evaluate overall survival, duration of overall response, and duration of stable disease.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Berlin
Country
Germany
Facility Name
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.
City
Milano
Country
Italy
Facility Name
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.
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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