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Lung CancerPhase 2NCT00979212

Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

A Phase 2 study testing panitumumab, carboplatin and paclitaxel in people with Lung Cancer, run by Radiation Therapy Oncology Group at 31 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: Drugs used in chemotherapy (CT), such as paclitaxel and 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 (RT) uses high-energy x-rays to kill tumor cells. 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?
panitumumab, carboplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
31 sitesUnited States
Study dates
Feb 2011to 20 May 2022
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed* non-small cell lung cancer (NSCLC), including any of the following histologies:
  • Adenocarcinoma
  • Adenosquamous
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
  • NSCLC not otherwise specified NOTE: *Documentation of NSCLC may originate from the mediastinal node biopsy or aspiration
  • Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar nodes (N1)
  • N2 nodes must be separate from primary tumor by either CT scan or surgical exploration
  • Maximum nodal diameter of involved N2 nodes cannot exceed 3.0 cm
  • N2 status must be pathologically confirmed to be positive by one of the following methods*:
  • Mediastinoscopy
  • Mediastinotomy (Chamberlain procedure)
  • Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)
  • Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)
  • Thoracotomy
  • Video-assisted thoracoscopy
  • Transbronchial needle biopsy by Wang technique (TBNA)
  • Fine-needle aspiration under CT guidance NOTE: *PET positivity in the ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal status
  • Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied unless all of the following are true:
  • Tumor is left sided
  • Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
  • Nodes visible in the anterior/posterior (level 5) region on CT scan
  • Distinct primary tumor separate from nodes visible on CT scan
  • Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor
  • If lymph nodes in the contralateral mediastinum and neck are visible on contrast CT scan of the chest and are > 1.0 cm in short axis or if contralateral involvement is suggested by PET scan, then the nodes must be confirmed to be negative
  • Measurable disease as determined by contrast-enhanced CT scan
  • Primary lung tumor distinct from mediastinal lymph nodes
  • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable M1a disease):
  • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
  • Exudative pleural effusions are excluded, regardless of cytology;
  • Effusions that are minimal (i.e. not visible under ultrasound guidance) that are too small to safely tap are eligible.
  • No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless proven to be benign by fine-needle aspiration or biopsy
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
  • Creatinine clearance ≥ 60 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Serum albumin > 3.0 g/dL
  • Serum magnesium normal (supplementation allowed)
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of treatment
  • Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1 ≥ 0.8 L
  • Diffusion capacity ≥ 50% predicted
  • No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
  • Current uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (<50%)
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or that would preclude study therapy within the past 4 weeks
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS or known HIV positivity
  • No unintentional weight loss ≥ 5% of body weight within the past 6 months
  • No prior severe infusion reaction to a monoclonal antibody
  • No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy or biological therapy (including erlotinib hydrochloride or similar agents) for the study cancer
  • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No prior therapy that specifically and directly targets the EGFR pathway

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites
  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

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

    Rochester, New York, 14642

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Cancer Institute at St. Joseph Medical Center

    Towson, Maryland, 21204

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

About this study

Official title: Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab (IND #110152) Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy (CT), such as paclitaxel and 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 (RT) uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as panitumumab, 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without panitumumab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see how well they work when given with or without panitumumab in treating patients with stage IIIA non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab in patients with stage IIIA non-small cell lung cancer.

Secondary

  • Assess overall survival of these patients.
  • Evaluate patterns of first failure in these patients.
  • Determine the acute and late adverse events associated with these regimens.
  • Assess surgical morbidities in patients with resectable disease at reassessment.
  • Determine the correlation between pre- and post-treatment biomarkers (including epidermal growth factor receptor (EGFR) and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival).
  • Evaluate the prognostic value of plasma osteopontin and microRNA for overall survival.
  • Assess the ability of FDG-PET/CT scan re-staging to predict outcome.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo intensity-modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
  • Arm II: Patients receive induction therapy comprising panitumumab IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 8, 15, 22, 29, and 36. Patients also undergo IMRT or 3D-CRT once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
  • In both arms, patients with resectable disease and no disease progression may proceed to surgery (thoracotomy, lobectomy, or pneumonectomy) approximately 4-6 weeks after completion of induction therapy. After surgery, patients proceed to consolidation therapy.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions
Lung Cancer
Being tested
panitumumab, carboplatin, paclitaxel, surgery
Keywords
stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous 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.

  • panitumumabDrug

    Also called Vectibix

    Induction: 2.5 mg/kg, IV, days 1, 8, 15, 22, 29, 36 of radiation therapy before administration of chemotherapy and radiation therapy.

  • carboplatinDrug

    Also called Paraplatin

    Induction: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. Consolidation, 6-12 weeks following surgery, AUC=6, IV, days 1 and 22.

  • paclitaxelDrug

    Also called Taxol, Abraxane

    Induction: 50 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. Consolidation, 6-12 weeks following surgery, 200 mg/m2, IV, days 1 and 22.

  • surgeryProcedure or surgery

    Also called lobectomy, pneumonectomy

    A lobectomy or pneumonectomy performed 4-6 weeks after completion of induction chemoradiation

Study groups in NCT00979212
Study groupRoleWhat they receive
Induction CT+RTActive comparatorChemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Receives: Drug: carboplatin; Drug: paclitaxel; Procedure: surgery
Induction CT+RT+PanitumumabExperimentalPanitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Receives: Drug: panitumumab; Drug: carboplatin; Drug: paclitaxel; Procedure: surgery

What is being measured

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

  1. Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.

    The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.

    Measured: From date of randomization to time of protocol surgery, approximately 12 weeks.

Secondary outcomes (6)
  1. Overall Survival

    Survival time was calculated from the date of randomization to the date of death from any cause or the date of last follow-up. The Kaplan-Meier method was used to estimate the overall survival rates. One-year survival rates were estimated, not compared.

    Measured: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study

  2. Patterns of First Failure

    The first failure site will be tabulated, not compared.

    Measured: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.

  3. Percentage of Patients With Grade 3 or Higher Acute and Late Adverse Events

    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Does not include surgical morbidities. An acute adverse event is defined as any grade 3 or worse toxicity occurring during protocol treatment and within 30 days from the end of protocol treatment that is possibly, probably, or definitely related to treatment. Acute adverse events are any adverse events occurring within 30 days of the end of all protocol treatment. Late adverse events are any adverse events occurring after 30 days after the end of all protocol treatment.

    Measured: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.

  4. Surgical Morbidities in Patients With Resectable Disease at Reassessment

    A surgical morbidity is any toxicity occurring within 30 days of protocol surgery, as evaluated using CTCAE v4.0. Rates of grade 3 and higher surgical morbidity were calculated; the rates across arms were not compared.

    Measured: From date of surgery to 30 days following surgery.

  5. Ability of FDG-PET/CT Scan Data to Predict Outcome

    Measured: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.

  6. Response Rate

    Patients are assessed for best response to protocol treatment using the RECIST criteria. The response rate was calculated as the number of patients who have a complete response (CR) or partial response (PR) divided by the total number of analyzable patients at completion of induction chemoradiation +/- panitumumab and prior to anticipated surgery in each arm. Patients without a documented assessment are considered as not having a CR or PR. Rates are not compared across arms.

    Measured: From date of randomization to time of protocol surgery, approximately 12 weeks.

Timeline

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

  1. First posted17 Sep 2009 (estimated)
  2. Study startFeb 2011
  3. Primary completionDec 2015
  4. Study completion20 May 2022

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
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979212
Sponsor's protocol ID
RTOG-0839
Other IDs
CDR0000654690, NCT00979212, NCI-2011-01970
Status last verified
May 2022
First submitted
16 Sep 2009
Last updated
15 Jun 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing panitumumab, carboplatin and paclitaxel in people with Lung Cancer, run by Radiation Therapy Oncology Group at 31 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 16 Aug 2016). 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?

Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab. (time frame: From date of randomization to time of protocol surgery, approximately 12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Jun 2022.

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