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Lung CancerPhase 2NCT00117962

Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer

A Phase 2 study testing cetuximab, carboplatin and pemetrexed disodium in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 71 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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, carboplatin and pemetrexed disodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
71 sitesUnited States
Study dates
Sep 2005to Sep 2012
Phase
Phase 2
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
  1. Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma including bronchoalveolar cell, and large cell anaplastic carcinoma (including giant and clear cell carcinomas)
  2. Eligible Disease Stages: Inoperable IIIA and Selected IIIB - Patients entered must be considered unresectable or inoperable. Patients do not need to have a mediastinoscopy. A size of 2 cm or greater by CT is a sufficient criterion for the diagnosis of mediastinal lymph node (N2 or N3) involvement by malignancy. If the largest mediastinal lymph node is less than 2 cm in diameter, a biopsy confirmation of mediastinal nodal involvement is required.
  3. The following patients are eligible:
  • Patients must be M0
  • Patients with any T with N2 or N3 are eligible
  • Patients with T3, N1-N3 disease are eligible if deemed unresectable
  • Patients with T4, any N are eligible provided the T4 status is not determined because of malignant effusion
  • Patients with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed in the radiation field in accordance with the homogeneity criteria
  • Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
  • If a pleural effusion can be seen on the chest CT but not on CXR and is too small to tap, the patient will be eligible. Patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible.
  1. The following patients are NOT eligible:
  • Patients with T3, N0 disease
  • Patients with M1 disease
  • Patients with atelectasis of the entire lung
  • Patients with direct invasion of vertebral body
  • Patients with scalene, supraclavicular, or contralateral hilar node involvement
  • Patients with exudative, bloody, or cytologically malignant effusions
  1. Patients must have Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan. Lesions that are not considered measurable include bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, abdominal masses that are not confirmed and followed by imaging techniques, cystic lesions and tumor lesions situated in a previously irradiated area.
  2. Prior Therapy: ≥ 2 weeks since formal exploratory thoracotomy. No prior chemotherapy for NSCLC, chest radiation therapy or therapy that specifically and directly targets the EGFR pathway
  3. ECOG performance status 0-1
  4. Positron Emission Tomography (PET) using 18 fluorodeoxyglucose (FDG) must be negative for distant metastasis. PET imaging is mandatory.
  5. Weight loss of ≤ 10% in the past 3 months
  6. No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
  7. Non-pregnant and non-nursing because of significant risk to the fetus/infant
  8. Age ≥ 18 years
  9. No patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
  10. No HIV-positive patients receiving combination anti-retroviral therapy because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy
  11. No known history of hypersensitivity to carboplatin, pemetrexed or a monoclonal antibody
  12. Required Initial Laboratory Values:
  13. Granulocytes ≥ 1,500/mcl
  14. Platelets ≥ 100,000/mcl
  15. Calculated Creatinine Clearance ≥ 45 ml/min
  16. Bilirubin < 1.5 x ULN
  17. AST/ALT < 3 x ULN
  18. Alkaline Phosphatase < 3 x ULN

Trial locations and contacts

71 sites in 1 country.

71 sites in 1 country

United States71 sites

  • Arroyo Grande Community Hospital

    Arroyo Grande, California, 93420

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Eden Medical Center

    Castro Valley, California, 94546

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46815

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • Bendheim Cancer Center at Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Saint Rose Hospital

    Hayward, California, 94545

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Callahan Cancer Center at Great Plains Regional Medical Center

    North Platte, Nebraska, 69103

  • Southwest Virginia Regional Cancer Center at Wellmonth Health

    Norton, Virginia, 24273

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Associates - Mercy Campus

    Oklahoma City, Oklahoma, 73120

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

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

    Savannah, Georgia, 31403-3089

  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis

    St Louis, Missouri, 63110

  • St. Anthony's Cancer Center

    St Louis, Missouri, 63128

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services, Incorporated at Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: A Randomized Phase II Study of Radiation Therapy, Pemetrexed and Carboplatin With or Without Cetuximab in Stage III Non-Small Cell Lung Cancer

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 make tumor cells more sensitive to radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation therapy together with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and carboplatin together with radiation therapy with or without cetuximab works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the overall survival of patients with unresectable stage III non-small cell lung cancer treated with pemetrexed disodium, carboplatin, and thoracic radiotherapy with or without cetuximab.

Secondary

  • Determine the failure-free survival and response rates in patients treated with these regimens.
  • Correlate epidermal growth factor receptor, erbB2, and K-ras mutations with survival and tumor response in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

  • Chemoradiotherapy (courses 1-4): Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
  • Arm II: Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
  • Consolidation chemotherapy (courses 5-8): Beginning 3-5 weeks after completion of chemoradiotherapy, all patients receive consolidation chemotherapy comprising pemetrexed disodium alone IV over 10 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study within 10-13 months.

Conditions
Lung Cancer
Being tested
cetuximab, carboplatin, pemetrexed disodium, radiation therapy
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

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

  • cetuximabBiological

    400 mg/sq m IV over 120 min: Day 1; Week 1 250 mg/sq m IV over 60 min weekly for 6 more weeks.

  • carboplatinDrug

    AUC = 5 q 21 days for 4 cycles

  • pemetrexed disodiumDrug

    500 mg/sq m IV q 21 days during chemoradiation and consolidation chemotherapy phases

  • radiation therapyRadiation

    Thoracic radiotherapy: 70 Gy for 7 weeks beginning on Day 1.

Study groups in NCT00117962
Study groupRoleWhat they receive
Std Tx + PemetrexedExperimentalPatients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Receives: Drug: carboplatin; Drug: pemetrexed disodium; Radiation: radiation therapy
Std Tx + Pemetrexed and CetuximabExperimentalPatients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
Receives: Biological: cetuximab; Drug: carboplatin; Drug: pemetrexed disodium; Radiation: radiation therapy

What is being measured

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

  1. 18 Month Survival

    Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.

    Measured: 18 months (from randomization)

Secondary outcomes (2)

  1. Failure-free Survival

    Failure-free survival (FFS) is the time from randomization to a failure event, defined as disease progression or death from any cause (which ever occurred first). The median FFS with 95% CI was estimated using the Kaplan-Meier method,

    Measured: Time from randomization to failure (up to 4 years)

  2. Number of Participants With Overall Tumor Response

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

    • Complete Response (CR): disappearance of all target lesions;
    • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
    • Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
    • Stable Disease (SD): small changes that do not meet above criteria.

    Overall tumor response is the total number of CR and PRs.

    Measured: Duration of study until progression (up to 4 years)

Timeline

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

  1. First posted11 Jul 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionMar 2009
  4. Study completionSep 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00117962
Sponsor's protocol ID
CALGB 30407
Other IDs
U10CA031946, CDR0000434616
Status last verified
Aug 2016
First submitted
8 Jul 2005
Last updated
7 Oct 2016
Data monitoring committee
No

Publications

  • Govindan R, Bogart J, Stinchcombe T, Wang X, Hodgson L, Kratzke R, Garst J, Brotherton T, Vokes EE. Randomized phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B trial 30407. J Clin Oncol. 2011 Aug 10;29(23):3120-5. doi: 10.1200/JCO.2010.33.4979. Epub 2011 Jul 11.

    PubMed 21747084

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, carboplatin and pemetrexed disodium in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 71 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: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Jan 2013). 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?

18 Month Survival (time frame: 18 months (from randomization)). 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 NCT00117962, which also lists 1 linked publication.

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 7 Oct 2016.

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