A Study of Enzastaurin and Erlotinib in Patients With Solid Tumors and Lung Cancer

Official Title: A Phase 1/2 Trial of Enzastaurin and Erlotinib in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer (NSCLC) After Prior Chemotherapy

Basic Trial Information

Phase Type Age Sponsor Protocol IDs
Phase 1/2 Treatment 18 and over Eli Lilly and Company UCSF 07651
H6Q-MC-S030
NCT00452413

Principal Investigator

Dubey TOP lab 

Sarita Dubey, MD
Assistant Professor of Medicine
Division of Hematology Oncology, UCSF

Trial Description

Phase II: A study to see how long patients with non-small cell lung cancer treated with Enzastaurin and Erlotinib live

Note:  UCSF is only participating in the Phase 2 portion of this study. 

Eligibility

Eligibility criteria include the following:

  • Phase 2: Histologic or cytologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV per American Joint Committee on Cancer Staging Criteria for NSCLC.
  • Patients must have failed 1 or 2 prior systemic treatment regimen(s).
  • No prior treatment with an epidermal growth factor receptor (EGFR) inhibitor, including erlotinib.
  • For more information about the eligibility criteria for this trial, please refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting it.

Detailed Description

In this study, enzastaurin will be given in combination with a cancer medication called erlotinib.  The purpose of this study is to find out what effects, good and/or bad, the combination of enzastaurin and erlotinib has on you and your stage of cancer.  Enzastaurin is an experimental drug which means that it has not been approved by the Food and Drug Administration (FDA).

The primary purpose of your participation in this study is to help answer the following research questions and not to provide you treatment for your condition:

  • How safe is enzastaurin when given in combination with erlotinib?
  • What are the side effects of this combination?
  • Does enzastaurin and erlotinib given together help patients with NSCLC?
  • Are there any genes or proteins in your lung cancer that affect how you respond to treatment?

Eli Lilly and Company is sponsoring this study and is providing Enzastaurin at no cost to you.  Erlotinib will be paid for by you or your insurance.

 

Important

Final eligibility is determined by the health professionals conducting the trial. For more information about this trial, refer to the more detailed Health Professional Version on the NCI website www.cancer.gov, and the Patient Consent Form approved by the Institutional Review Board (IRB) at the University of California, San Francisco (UCSF).

For More Information

For questions about this trial or eligibility, please contact:


Greg Nalbandian
Clinical Study Coordinator
UCSF Comprehensive Cancer Center
(415) 353-7710 Phone
(415) 353-9721 Fax
nalbandiang@surgery.ucsf.edu 

Note: The information above was reproduced or adapted from descriptions on the websites of the National Cancer Institute (NCI) at http://www.cancer.gov/, the National Library of Medicine (NLM) at http://www.clinicaltrials.gov/, and from the Consent Form approved by the Institutional Review Board (IRB) at the University of California, San Francisco (UCSF).