Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.

Detailed description:
OUTLINE: This is a multi-center study.

Week 1 (day 1):

* Cetuximab 400mg/m2

Week 2 (Cycle 1, Day 1):

* Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.

Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.

Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles.

Acceptable toxicity and SD, PR or CR: treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity

Performance status: ECOG 0-2

Life expectancy: At least 12 weeks

Hematopoietic:

* ANC \> 1,500/mm3
* Platelets \> 100,000/mm3

Hepatic:

* Bilirubin less than or equal to the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 1.5 X ULN. AST may be \< 5 X ULN for patients with liver metastases
* Alkaline phosphatase \< 5 X ULN

Renal:

* Calculated creatinine clearance \> 45 mL/min (by Cockcroft-Gault)

Cardiovascular:

* No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)

Pulmonary:

* Not specified

Arms:
arm 1: Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.

Interventions: intervention 1: Pemetrexed intervention 2: Cetuximab
Intervention descriptions: intervention 1: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles intervention 2: Cetuximab 400 mg/m2, week 1, day 1

Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle

Protocol document: