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Lung CancerPhase 1NCT00288054

S0429: Docetaxel, Cetuximab, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

A Phase 1 study testing cetuximab, docetaxel and radiation therapy in people with Lung Cancer, run by SWOG Cancer Research Network at 77 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cetuximab, docetaxel and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
77 sitesUnited States
Study dates
Apr 2006to Apr 2012
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West

    Boca Raton, Florida, 33428

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

    Boca Raton, Florida, 33486

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Caritas St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135-2997

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Northern Montana Hospital

    Havre, Montana, 59501

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Ted B. Wahby Cancer Center at Mount Clemens General Hospital

    Mount Clemens, Michigan, 48043

  • Hematology Oncology Consultants - Naperville

    Naperville, Illinois, 60540

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Olathe Cancer Center

    Olathe, Kansas, 66061

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • 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 - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
cetuximab, docetaxel, radiation therapy
Keywords
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
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabBiological

    Cohorts 1 and 2: 400 mg/m2 (initial dose) 2 hour IV infusion on Day 1, Cycle 1 only.

    250 mg/m2, 1 hour IV infusion on Days 8 , 15 and 22 during Cycle 1. 250 mg/m2 (subsequent doses), 1 hour IV infusion on Days 1, 8 , 15 and 22 during subsequent cycles.

  • docetaxelDrug

    Cohort 2 ONLY: 20 mg/m2 IV over 15 - 30 minutes on Days 8, 15 and 22 of Cycle 1. Concurrent with RT and cetuximab starting at Week 2.

    20 mg/m2 IV over 15 - 30 minutes on Days 1, 8, 15 and 22 of Cycle 2.

  • radiation therapyRadiation

    Radiation therapy should begin on Day 8 of Cycle 1 and continue through the end of Cycle 2. Refer to Section 12.1 for Radiation Therapy Review.

    RT prescription should be PTV (GTV + 2-cm margins on CT scan) to 6,480 cGy in 36 fractions given 5 days a week, 180 cGy per day. The dose is prescribed to the isocenter. The entire treatment should be planned prior to starting treatment to ensure that the plan meets protocol specifications.

Study groups in NCT00288054
Study groupRoleWhat they receive
Cetuximab + Radiotherapy (no Docetaxel)ExperimentalNot described
Receives: Biological: cetuximab; Radiation: radiation therapy
Cetuximab + Radiotherapy + DocetaxelExperimentalNot described
Receives: Biological: cetuximab; Drug: docetaxel; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (4)

  1. Toxicity

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.

  2. 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.

    Measured: weekly while patient is on protocol treatment, then monthly thereafter.

  3. 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.

    Measured: At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.

  4. 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.

    Measured: Week 10 and week 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionApr 2012
  4. Study completionApr 2012

Why it stopped: Study closed early due to poor accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00288054
Sponsor's protocol ID
CDR0000456381
Other IDs
U10CA032102, S0429
Status last verified
Jan 2013
First submitted
6 Feb 2006
Last updated
4 Jan 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cetuximab, docetaxel and radiation therapy in people with Lung Cancer, run by SWOG Cancer Research Network at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related Esophagitis or Pneumonitis (time frame: Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00288054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.

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