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Pharmacodynamic Separation of Pemetrexed and Erlotinib as Second-line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Montefiore Medical Center.
Recruitment status was:  Recruiting
Eli Lilly and Company
OSI Pharmaceuticals
Information provided by:
Montefiore Medical Center Identifier:
First received: July 30, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

RATIONALE: Erlotinib may stop the growth of tumor cells, and even shrink the tumors in some patients, by blocking some of the enzymes such as epidermal growth factor receptor (EGFR) needed for cell growth and spread. Pemetrexed is a drug that inhibits several key proteins that require folic acid to synthesize DNA. Blocking DNA synthesis in tumor cells has been shown to decrease tumor growth. can block tumor growth in different ways. Giving erlotinib together with pemetrexed at a specific schedule may kill more tumor cells than giving only pemetrexed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Pemetrexed
Drug: pemetrexed and erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed and Erlotinib Versus Single Agent Pemetrexed in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Every 6 weeks while on study ]
  • Disease control rate [ Time Frame: 6 months ]
  • Safety profile of pemetrexed and erlotinib combination [ Time Frame: Continously ]
  • Assessment of molecular markers for biologic effects and predictive response [ Time Frame: while on study ]

Estimated Enrollment: 82
Study Start Date: May 2006
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Pemetrexed Monotherapy
Drug: Pemetrexed
500 mg/m2 IV over 10 minutes on day 1 every 21 days
Experimental: B
Pharmacodynamic separation of pemetrexed and erlotinib
Drug: pemetrexed and erlotinib
pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days and erlotinib 150 mg PO once daily on days 2-17 every 21 days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed advanced (Stage IIIB with a malignant pleural effusion or Stage IV disease) or recurrent nonsquamous NSCLC.
  • Patients must have at least one measurable disease per RECIST criteria
  • Patient must have disease progression after one prior chemotherapy and/or targeted therapy other than pemetrexed or anti-EGFR therapy for metastatic disease, or relapse while receiving adjuvant therapy, or within 12 months of completing adjuvant therapy

Exclusion Criteria:

  • Patients who have had immunotherapy, hormone, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients with uncontrolled brain metastases should be excluded from this clinical trial because of their poor prognosis.
  • Patients with immune deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00950365

Contact: Tianhong Li, MD, PhD 718-904-2900
Contact: Cheryl Baker, APRN 718-405-8508

United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Bilal Piperdi, MD    508-856-3702   
Principal Investigator: Bilal Piperdi, MD         
Sub-Investigator: William V Walsh, MD         
United States, New York
Albert Einstein Cancer Center Recruiting
Bronx, New York, United States, 10461
Contact: Tianhong Li, MD, PhD    718-904-2900   
Contact: Cheryl Baker, APRN    718-405-8508   
Principal Investigator: Tianhong Li, MD, PhD         
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Rasim Gucalp, MD    718-920-4826   
Contact: Yoko Eng, RN    718-920-2090   
Sub-Investigator: Rasim Gucalp, MD         
Sponsors and Collaborators
Montefiore Medical Center
Eli Lilly and Company
OSI Pharmaceuticals
Study Chair: Tianhong Li, MD, PhD Montefiore Medical Center
  More Information

Responsible Party: Tianhong Li, MD, PhD, Montefiore Medical Center Identifier: NCT00950365     History of Changes
Other Study ID Numbers: Pemetrexed/Erlotinib
Study First Received: July 30, 2009
Last Updated: July 30, 2009

Keywords provided by Montefiore Medical Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
progressive or recurrent stage III or stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on May 25, 2017