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A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Cancer

Thank you

Trial Information

A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- histologic or cytologic diagnosis of NSCLC Stage IIIB or IV

- no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer

- Prior radiotherapy must be completed at least 4 weeks before study enrollment.

Exclusion Criteria:

- estimated life expectancy of 12 weeks

- a serious cardiac condition, such as myocardial infarction within 6 months, angina,
or heart disease

- documented brain metastases unless the patient has completed successful local therapy
for central nervous system metastases and has been off of corticosteroids for at
least 2 weeks before enrollment

- significant weight loss (that is, > 10%) over the previous 6 weeks before study
entry.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best Overall Tumor Response

Outcome Time Frame:

baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9431

NCT ID:

NCT00383331

Start Date:

February 2007

Completion Date:

January 2008

Related Keywords:

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

Name

Location

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  55404