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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489983
• Other study ID #: 5119
• Secondary ID: H3E-EW-JMEM
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: July 2003
• Est. completion date: March 2005

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionItaly: Ministry of HealthUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• pemetrexed

• gemcitabine

Locations

Country	Name	City	State
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
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate efficacy.
Secondary	To evaluate toxicity.
Secondary	To evaluate response.
Secondary	To evaluate overall survival, duration of overall response, and duration of stable disease.

External Links

•   Lilly Clinical Trial Registry