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

Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:May 2006
Contact:Tianhong Li, MD, PhD

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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)

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

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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced (Stage IIIB
with a malignant pleural effusion or Stage IV disease) or recurrent nonsquamous

- 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
We found this trial at
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Bronx, NY
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Bronx, New York 10461
Bronx, NY
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Worcester, Massachusetts 01655
Worcester, MA
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