Pharmacodynamic Separation of Pemetrexed and Erlotinib as Second-line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
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
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Pemetrexed Type: Drug
Name: pemetrexed and erlotinib Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
University of Massachusetts
Worcester, Massachusetts, United States
Status: Recruiting
Contact: Bilal Piperdi, MD - 508-856-3702 -
Albert Einstein Cancer Center
Bronx, New York, United States
Status: Recruiting
Contact: Tianhong Li, MD, PhD - 718-904-2900 -
Montefiore Medical Center
Bronx, New York, United States
Status: Recruiting
Contact: Rasim Gucalp, MD - 718-920-4826 -
Start Date
May 2006
Montefiore Medical Center
Montefiore Medical Center
Record processing date processed this data on July 28, 2015 page