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A Randomized, Open-label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-small Cell Lung Cancer (NSCLC)


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

Thank you

Trial Information

A Randomized, Open-label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- You must have been diagnosed with non-small cell lung cancer.

- You must be able to visit the doctor's office weekly during the active treatment
period and as needed during the study follow-up period.

- You must be willing and able to swallow capsules.

- Your entry labs and medical tests must meet study requirements.

- You must be willing to have blood samples drawn and tissue samples obtained for gene
and protein testing.

Exclusion Criteria:

- You have received radiation within 2 weeks of study enrollment.

- You have previously received any anti-cancer drug therapy for non-small cell lung
cancer.

- You have an active infection or other serious condition.

- You take aspirin or aspirin-like medication regularly and are not able to stop taking
them for a few days during each cycle of chemotherapy.

- You have recently lost a significant amount of weight.

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:

Time to progressive disease

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 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:

10651

NCT ID:

NCT00308750

Start Date:

March 2006

Completion Date:

July 2009

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. Durham, North Carolina  
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. Greenville, South Carolina  29605
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. Bedford, Texas  76022