Lung Cancer Clinical Trial
Official title:
A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
Verified date | January 2013 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 24 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio |
United States | Alaska Regional Hospital Cancer Center | Anchorage | Alaska |
United States | Hospital District Sixth of Harper County | Anthony | Kansas |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton | Florida |
United States | Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West | Boca Raton | Florida |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Caritas St. Elizabeth's Medical Center | Brighton | Massachusetts |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | Shaw Regional Cancer Center | Edwards | Colorado |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Valley View Hospital Cancer Center | Glenwood Springs | Colorado |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
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 | Northern Montana Hospital | Havre | Montana |
United States | St. Peter's Hospital | Helena | Montana |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Southwest Medical Center | Liberal | Kansas |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | MedCentral - Mansfield Hospital | Mansfield | Ohio |
United States | Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville | California |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown | New York |
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 | Montrose Memorial Hospital Cancer Center | Montrose | Colorado |
United States | Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens | Michigan |
United States | Hematology Oncology Consultants - Naperville | Naperville | Illinois |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Olathe Cancer Center | Olathe | Kansas |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Highland Hospital of Rochester | Rochester | New York |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | Cotton-O'Neil Cancer Center | Topeka | Kansas |
United States | Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta | Georgia |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Secondary | Toxicity | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment. | Yes |
Secondary | Overall Survival | 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. | weekly while patient is on protocol treatment, then monthly thereafter. | No |
Secondary | Progression-free Survival. | 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. | At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment. | No |
Secondary | Response Rate | 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. | Week 10 and week 22 | No |
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