S0429: Docetaxel, Cetuximab, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00288054
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with cetuximab and radiation therapy in treating patients with stage III non-small cell lung cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cetuximab + Radiotherapy (no Docetaxel) cetuximab - Cetuximab + Radiotherapy (no Docetaxel) radiation therapy - Cetuximab + Radiotherapy + Docetaxel cetuximab - Cetuximab + Radiotherapy + Docetaxel radiation therapy - Cetuximab + Radiotherapy + Docetaxel docetaxel -
- Primary Outcome Measures
Name Time Method Treatment-related Esophagitis or Pneumonitis Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy. The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.
- Secondary Outcome Measures
Name Time Method Toxicity Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Overall Survival weekly while patient is on protocol treatment, then monthly thereafter. The duration form the date of enrollment until the date of death due to any cause. Patients last known to be alive are censored at the date of last contact.
Progression-free Survival. At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment. Duration from the date of enrollment until the date of progression (as defined by RECIST: \>= 20% increase over baseline in the sum of longest diameters, or appearance of new lesions, or non-measurable disease that is clearly worsening in the opinion of the treating investigator, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and free of disease progression are censored at the date of last contact.
Response Rate Week 10 and week 22 Confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease (as defined per RECIST). A confirmed complete response (CR) is defined as disappearance of all disease, confirmed by a second determination of CR at least 4 weeks later. A confirmed partial response (PR) is defined as a \>= 30% decrease from baseline in the sum of longest diameters, confirmed by a second determination of PR at least 4 weeks later. A patient is considered to have measurable disease if they have at least one lesion with a longest diameter of \>= 2 cm by conventional CT, or \>= 1 cm by spiral CT.
Trial Locations
- Locations (76)
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
🇺🇸Boca Raton, Florida, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
🇺🇸Southfield, Michigan, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸Marysville, California, United States
Poudre Valley Hospital
🇺🇸Fort Collins, Colorado, United States
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West
🇺🇸Boca Raton, Florida, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Valley View Hospital Cancer Center
🇺🇸Glenwood Springs, Colorado, United States
Montrose Memorial Hospital Cancer Center
🇺🇸Montrose, Colorado, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Hospital District Sixth of Harper County
🇺🇸Anthony, Kansas, United States
Hematology Oncology Consultants - Naperville
🇺🇸Naperville, Illinois, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Olathe Cancer Center
🇺🇸Olathe, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Brighton, Massachusetts, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
🇺🇸Mount Clemens, Michigan, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
MedCentral - Mansfield Hospital
🇺🇸Mansfield, Ohio, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Shaw Regional Cancer Center
🇺🇸Edwards, Colorado, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States