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 because the information has not been verified recently.

Verified July 2009 by Montefiore Medical Center.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Eli Lilly and Company

OSI Pharmaceuticals

Information provided by:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT00950365

First received: July 30, 2009

Last updated: NA

Last verified: July 2009

History: No changes posted

Purpose

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 Endpoint Classification: Efficacy Study 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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate [ Time Frame: Every 6 weeks while on study ] [ Designated as safety issue: No ]
Disease control rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety profile of pemetrexed and erlotinib combination [ Time Frame: Continously ] [ Designated as safety issue: Yes ]
Assessment of molecular markers for biologic effects and predictive response [ Time Frame: while on study ] [ Designated as safety issue: No ]


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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 ClinicalTrials.gov identifier: NCT00950365

Contacts


Contact: Tianhong Li, MD, PhD	718-904-2900	tli@montefiore.org
Contact: Cheryl Baker, APRN	718-405-8508	cbaker@montefiore.org

Locations


United States, Massachusetts
University of Massachusetts	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Bilal Piperdi, MD 508-856-3702 piperdib@ummhc.org
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 tli@montefiore.org
Contact: Cheryl Baker, APRN 718-405-8508 cbaker@montefiore.org
Principal Investigator: Tianhong Li, MD, PhD
Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10467
Contact: Rasim Gucalp, MD 718-920-4826 rgucalp@montefiore.org
Contact: Yoko Eng, RN 718-920-2090 yeng@montefiore.org
Sub-Investigator: Rasim Gucalp, MD

Sponsors and Collaborators

Montefiore Medical Center

Eli Lilly and Company

OSI Pharmaceuticals

Investigators


Study Chair:	Tianhong Li, MD, PhD	Montefiore Medical Center

More Information

No publications provided


Responsible Party:	Tianhong Li, MD, PhD, Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00950365 History of Changes
Other Study ID Numbers:	Pemetrexed/Erlotinib
Study First Received:	July 30, 2009
Last Updated:	July 30, 2009
Health Authority:	United States: Institutional Review Board

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:


Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Erlotinib	Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

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