A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab
12 months
Yes
Nasser Hanna, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Food and Drug Administration
HOG LUN04-79
NCT00216203
May 2005
December 2008
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
Oncology Hematology Care, Inc. | Cincinnati, Ohio 45219 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Texas Oncology Cancer Center | Austin, Texas 78731 |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Elkhart Clinic | Elkhart, Indiana 46515 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Greenebaum Cancer Center | Baltimore, Maryland 21201 |