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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),
including any of the following subtypes:

- Squamous cell carcinoma

- Adenocarcinoma (including bronchoalveolar cell carcinoma)

- Large cell anaplastic carcinoma (including giant cell and clear cell carcinoma)

- Stage IIIA OR selected stage IIIB disease*

- Any T, N2-3, M0 disease

- T3, N1-3, M0 disease allowed provided disease is unresectable

- T4, any N, M0 disease allowed provided T4 status cannot be determined due to
malignant effusion

- No T3, N0, M0 disease NOTE: *If the largest mediastinal lymph node is < 2 cm in
diameter by CT scan, a biopsy confirmation of mediastinal nodal involvement is
required

- Unresectable disease

- Contralateral mediastinal disease (N3) allowed provided all gross disease can be
encompassed within the radiation field in accordance with the homogeneity criteria

- Measurable disease, defined as ≥ 1 one-dimensional measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- The following are not considered measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions in a previously irradiated area

- No exudative, bloody, or cytologically positive malignant effusion

- Transudate, cytologically negative, non-bloody pleural effusion allowed provided
the tumor can be encompassed within a reasonable field of radiotherapy

- Pleural effusion detectable by chest CT scan but not by chest x-ray that is too
small to tap

- New pleural effusion appearing after thoracotomy or other invasive thoracic
procedure allowed

- No atelectasis of the entire lung

- No direct invasion of the vertebral body

- No scalene, supraclavicular, or contralateral hilar node involvement

- No distant metastases (M1) by fludeoxyglucose F18 positron emission tomography

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin < 1.5 times upper limit of normal (ULN)

- AST and ALT < 3 times ULN

- Alkaline phosphatase < 3 times ULN

Renal

- Creatinine clearance ≥ 45 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Weight loss ≤ 10% within the past 3 months

- No other active* malignancy except nonmelanoma skin cancer

- No ongoing or active infection

- No other uncontrolled illness

- No history of hypersensitivity to carboplatin, pemetrexed disodium, or a monoclonal
antibody NOTE: *Malignancy is not considered active if the patient has completed
treatment and has < 30% risk of relapse

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during
thoracic radiotherapy or as prophylaxis for myelosuppression

Chemotherapy

- No prior chemotherapy for NSCLC

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy except megestrol for appetite stimulation or
dexamethasone to prevent rash from pemetrexed disodium

Radiotherapy

- No prior radiotherapy to the chest

- No concurrent palliative radiotherapy

- No concurrent intensity modulated radiotherapy

Surgery

- See Disease Characteristics

- At least 2 weeks since prior formal exploratory thoracotomy

Other

- No prior therapy that directly targets the epidermal growth factor receptor pathway

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

18 Month Survival

Outcome Description:

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

Outcome Time Frame:

18 months (from randomization)

Safety Issue:

No

Principal Investigator

Ramaswamy Govindan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000434616

NCT ID:

NCT00117962

Start Date:

September 2005

Completion Date:

September 2012

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Sibley Memorial HospitalWashington, District of Columbia  20016
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Eden Medical CenterCastro Valley, California  94546
Saint Rose HospitalHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health CenterGrand Island, Nebraska  68803
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Highland General HospitalOakland, California  94602
Saint Luke's HospitalChesterfield, Missouri  63017
Missouri Cancer AssociatesColumbia, Missouri  65201
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Arch Medical Services, Incorporated at Center for Cancer Care and ResearchSaint Louis, Missouri  63141
Cancer Care Associates - Mercy CampusOklahoma City, Oklahoma  73120
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Pardee Memorial HospitalHendersonville, North Carolina  28791
Kinston Medical SpecialistsKinston, North Carolina  28501
Miriam HospitalProvidence, Rhode Island  02906
McLeod Regional Medical CenterFlorence, South Carolina  29501
La Grange Memorial HospitalLa Grange, Illinois  60525
Lakes Region General HospitalLaconia, New Hampshire  03246
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Arroyo Grande Community HospitalArroyo Grande, California  93420
St. Anthony's Cancer CenterSt. Louis, Missouri  63128
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntington, West Virginia  25702
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint LouisSt Louis, Missouri  63110
Callahan Cancer Center at Great Plains Regional Medical CenterNorth Platte, Nebraska  69103
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
Bendheim Cancer Center at Greenwich HospitalGreenwich, Connecticut  06830
Upper Chesapeake Medical CenterBel Air, Maryland  21014