A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Test the feasibility and toxicity of combined cetuximab, weekly docetaxel, and
concurrent radiotherapy in patients with poor-risk stage III non-small cell lung cancer
(NSCLC).
Secondary
- Evaluate response rates (confirmed and unconfirmed, complete and partial) as well as
overall and progression-free survival.
- Correlate EGFR mutations, KRAS mutations, EGFR/HER2 gene copy number detected by FISH,
and protein expression by immunohistochemistry of EGFR-HER signaling pathways,
phosphorylation, proliferative markers, apoptotic markers, selected oncogene markers,
and markers for angiogenesis in biopsied pre-treatment tumor tissues with response and
survival outcomes.
- Explore possible associations between changes in plasma angiogenic factors (VEGF, IL-8,
bFGF) and cytokine levels (IL-6, IL-1α, ICAM, TGF-β, and others) and the risk of
treatment-related pneumonitis and esophagitis.
OUTLINE: Patients are enrolled sequentially to 1 of 2 treatment groups.
- Cohort 1: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22.
- Cohort 2: Patients receive cetuximab as in group 1 followed by docetaxel IV over 15-30
minutes on days 8, 15, and 22 of course 1 and on days 1, 8, 15, and 22 of course 2.
Initially, 27 patients will be enrolled in Cohort 1. Once all patients in Cohort 1 have
discontinued treatment, if toxicity rates are acceptable per protocol specifications, an
additional 27 patients will be enrolled to Cohort 2. Treatment in both cohorts repeats every
28 days for 2 courses in the absence of disease progression or unacceptable toxicity. All
patients also undergo radiotherapy once daily, 5 days a week, beginning on day 8 of course 1
and continuing through course 2 (approximately 7 weeks). Patients with no progressive
disease then receive cetuximab alone once weekly. Treatment with cetuximab alone continues
in the absence of disease progression for up to 2 years.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related Esophagitis or Pneumonitis
The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.
Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.
Yes
Yuhchyau Chen, MD, PhD
Principal Investigator
James P. Wilmot Cancer Center
United States: Federal Government
CDR0000456381
NCT00288054
April 2006
April 2012
Name | Location |
---|---|
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Wesley Medical Center | Wichita, Kansas 67214 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Southwest Medical Center | Liberal, Kansas 67901 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Hematology Oncology Consultants - Naperville | Naperville, Illinois 60540 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville, California 95901 |
Caritas St. Elizabeth's Medical Center | Brighton, Massachusetts 02135-2997 |
Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens, Michigan 48043 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton, Florida 33486 |
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West | Boca Raton, Florida 33428 |
Shaw Regional Cancer Center | Edwards, Colorado 81632 |
Valley View Hospital Cancer Center | Glenwood Springs, Colorado 81601 |
Olathe Cancer Center | Olathe, Kansas 66061 |