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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00124618
First received: July 26, 2005
Last updated: March 9, 2015
Last verified: March 2015
  Purpose

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.> PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: cetuximab
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 11-month Survival Rate [ Time Frame: From baseline to 11 months. ] [ Designated as safety issue: No ]
    Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with "success", unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.


Secondary Outcome Measures:
  • Survival Time [ Time Frame: From baseline to up to 3 years ] [ Designated as safety issue: No ]
    Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

  • Time to Disease Progression [ Time Frame: From Baseline to up to 3 years ] [ Designated as safety issue: No ]
    Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.

  • Tumor Response (Complete and Partial) [ Time Frame: Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration ] [ Designated as safety issue: No ]
    A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.


Enrollment: 58
Study Start Date: January 2006
Study Completion Date: May 2011
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cetuximab/Radiation
Cetuximab (C225) and Radiation
Biological: cetuximab Radiation: radiation therapy

Detailed Description:

OBJECTIVES:> Primary>

  • Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy.> Secondary>
  • Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen.>
  • Determine the toxicity of this regimen in these patients.>
  • Determine whether fear of death is less severe in the oldest of patients treated with this regimen.>
  • Determine whether fear of death predicts survival of patients treated with this regimen.> OUTLINE: This is a multicenter study.> Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years.> PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months>
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) >

    • Stage IIIA or IIIB disease >
  • Must be a candidate for curative radiotherapy >
  • Not a candidate for other concurrent chemotherapy and radiotherapy
  • No surgical treatment available
  • No pleural effusion suspected or proven to be malignant >
  • No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days >

PATIENT CHARACTERISTICS:

> Age

  • 18 and over

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years) >
  • ECOG 2 (age 18 to 64 years)

Life expectancy

>

* At least 12 weeks

>

> Hematopoietic

>

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3 >
  • Hemoglobin ≥ 9 g/dL

Hepatic >

  • Bilirubin ≤ 2 times upper limit of normal (ULN) >
  • AST ≤ 3 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Pulmonary

  • FEV_1 ≥ 1 L
  • No idiopathic pulmonary fibrosis >

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception >
  • Magnesium normal
  • No uncontrolled infection
  • No other severe underlying disease that would preclude study entry >
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
  • No major psychiatric illness that would preclude study participation >

PRIOR CONCURRENT THERAPY:

> Biologic therapy

  • Not specified >

Chemotherapy >

  • See Disease Characteristics >
  • No prior chemotherapy for NSCLC

Endocrine therapy

>

* Not specified

>

> Radiotherapy

  • No prior therapeutic radiotherapy to the chest >
  • No concurrent intensity modulated radiotherapy

Surgery >

  • Not specified

Other

  • No prior epidermal growth factor receptor inhibitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124618

  Show 175 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
Principal Investigator: Steven E Schild, M.D Mayo Clinic
Principal Investigator: Kenneth Dornfeld, M.D North Central Cancer Treatment Group
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00124618     History of Changes
Other Study ID Numbers: NCCTG-N0422, NCI-2012-02664, CDR0000435991
Study First Received: July 26, 2005
Results First Received: March 9, 2015
Last Updated: March 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015