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A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically proven newly diagnosed single, primary, bronchogenic
stage IIIA or selected stage IIIB (excluding malignant pleural effusion) non-small
cell lung cancer (NSCLC) of one of the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified

- Histology or cytology from involved mediastinal or supraclavicular nodes will be
sufficient for diagnosis if a separate primary lesion of the lung parenchyma is
clearly evident on radiographs (i.e., a second biopsy will not be required)

- Underwent positron emission tomography (PET) scan within the past 42 days

- N2 or N3 mediastinal disease by PET scan OR enlarged nodes on CT scan determined
to be N2 or N3 by biopsy

- Measurable disease, defined as lesions that can be accurately measured in at least
one dimension as ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan

- Pleural effusion, ascites, bone lesions, and laboratory parameters are not
considered measurable disease

- No brain metastases

- Malignant pleural effusion allowed provided 1 of the following is true:

- Present before mediastinoscopy or exploratory thoracotomy AND the pleural fluid
is transudate with negative cytology

- Present only after but not before exploratory or staging thoracotomy AND the
pleural fluid is either transudate or exudate with negative cytology

- Present only on CT scan but not on decubitus chest x-ray AND deemed too small to
tap under either CT scan or ultrasound guidance

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1, meeting ≥ 1 of the following criteria OR Zubrod
performance status 2 with no co-morbidities or meeting 1 of the following criteria:

- No co-morbidities

- FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

- DLCO > 10 mL/mm Hg/min

- Albumin < 0.85 times lower limit of normal

- Unintentional weight loss > 10% within the past 6 months

- Controlled congestive heart failure which, in the opinion of the investigator,
may become decompensated due to radiotherapy

- FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Must provide prior smoking history

- Serum bilirubin normal

- Meets one of the following criteria:

- Alkaline phosphatase (AP) ≤ 4 times ULN AND SGOT or SGPT normal

- AP normal AND SGOT or SGPT ≤ 2.5 times ULN

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated
stage I or II cancer from which the patient is currently in complete remission

- No pregnant or nursing patients

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or curative surgery for this cancer

- No prior radiotherapy to the neck and/or thorax for any reason

- No prior therapy which specifically targets the EGFR pathway

- No concurrent growth factors (e.g., filgrastim [G-CSF], epoetin alfa, or
pegfilgrastim) or amifostine

- No concurrent intensity-modulated radiotherapy

- No concurrent prophylactic mediastinal, contralateral hilar, or supraclavicular lymph
node radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related Esophagitis or Pneumonitis

Outcome Description:

The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.

Outcome Time Frame:

Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.

Safety Issue:

Yes

Principal Investigator

Yuhchyau Chen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000456381

NCT ID:

NCT00288054

Start Date:

April 2006

Completion Date:

April 2012

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
University of California Davis Cancer CenterSacramento, California  95817
Wesley Medical CenterWichita, Kansas  67214
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Poudre Valley HospitalFort Collins, Colorado  80524
Hematology Oncology Consultants - NapervilleNaperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Highland Hospital of RochesterRochester, New York  14620
Iredell Memorial HospitalStatesville, North Carolina  28677
Danville Regional Medical CenterDanville, Virginia  24541
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Pardee Memorial HospitalHendersonville, North Carolina  28791
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California  95901
Caritas St. Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997
Ted B. Wahby Cancer Center at Mount Clemens General HospitalMount Clemens, Michigan  48043
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main CampusBoca Raton, Florida  33486
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - WestBoca Raton, Florida  33428
Shaw Regional Cancer CenterEdwards, Colorado  81632
Valley View Hospital Cancer CenterGlenwood Springs, Colorado  81601
Olathe Cancer CenterOlathe, Kansas  66061