Know Cancer

or
forgot password

A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- To determine the activity of induction chemotherapy comprising carboplatin and
paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic
radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage
IIIA or IIIB non-small cell lung cancer.

Secondary

- To determine the response rate and progression-free survival of these patients.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized
nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30
minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease
progression outside of the chest after induction therapy are removed from study. Patients
with intrathoracic disease progression within the potential radiation field may continue
protocol therapy at the discretion of the Study Chair. Patients with no disease progression
outside the planned radiation field (either regional or distant) proceed to concurrent
erlotinib hydrochloride and radiotherapy.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily.
Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions)
in the absence of rapid disease progression outside of the chest or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, and then
every 6 months for up to 2 years

Inclusion Criteria


DISEASE CHARACTERISTICS:

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

- Squamous cell carcinoma

- Adenocarcinoma (including bronchoalveolar cell)

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

- Must meet the following criteria:

- T1-3 with N2 and selected N3*

- T4 with N0, N1, N2 and selected N3*

- M0 (no M1 patients) NOTE: *Patients with contralateral mediastinal disease
(i.e., N3) are eligible, provided all gross disease can be encompassed within
the radiation boost field in accordance with the homogeneity criteria. Patients
with ipsilateral scalene or supraclavicular disease are also eligible. Patients
with contralateral hilar or supraclavicular node involvement are not eligible.

- Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20
mm by conventional techniques or ≥ 10 mm by spiral CT scan

- Nonmeasurable lesions include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions situated in a previously irradiated area

- Patients must be considered unresectable or inoperable AND be deemed candidates for
combined modality therapy by a medical oncologist and a radiation oncologist

- Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10%
weight loss within the past 3 months

- Patients with tumors adjacent to a vertebral body are eligible, provided all gross
disease can be encompassed within the radiation boost field in accordance with the
homogeneity criteria

- Pleural effusions meeting the following criteria allowed:

- Effusion is transudate, cytologically negative, and non-bloody

- Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too
small to tap

- Effusion appears only after a thoracotomy or other invasive thoracic procedure
was attempted

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- Granulocytes ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Creatinine ≤ 1.5 x upper limit of normal (ULN)

- AST < 2 x ULN

- Bilirubin ≤ ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy for NSCLC

- At least 2 weeks since formal exploratory thoracotomy

- No concurrent administration of sucralfate suspension and erlotinib hydrochloride

- No concurrent intensity-modulated radiotherapy

- No concurrent hormones or other chemotherapeutic agents except steroids given for
adrenal failure, hormones administered for non-disease-related conditions (e.g.,
insulin for diabetes), and intermittent use of dexamethasone as an antiemetic

- No concurrent palliative radiotherapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 12 months

Safety Issue:

No

Principal Investigator

Rogerio C. Lilenbaum, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Florida - Weston

Authority:

United States: Federal Government

Study ID:

CDR0000573832

NCT ID:

NCT00553462

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

National Naval Medical CenterBethesda, Maryland  20889
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Iredell Memorial HospitalStatesville, North Carolina  28677
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Danville Regional Medical CenterDanville, Virginia  24541
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Poudre Valley Radiation OncologyFort Collins, Colorado  80528
Highland General HospitalOakland, California  94602
Palo Alto Medical FoundationPalo Alto, California  94301
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
St. Joseph Medical CenterKansas City, Missouri  64114
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Rex Cancer Center at Rex HospitalRaleigh, North Carolina  27607
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Harold Alfond Center for Cancer CareAugusta, Maine  04330
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Kinston Medical SpecialistsKinston, North Carolina  28501
Lakes Region General HospitalLaconia, New Hampshire  03246
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Boston University Cancer Research CenterBoston, Massachusetts  02118
Parvin Radiation OncologyKansas City, Missouri  64116
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
El Camino Hospital Cancer CenterMountain View, California  94040
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
AnMed Cancer CenterAnderson, South Carolina  29621
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538
Southeastern Regional Medical CenterLumberton, North Carolina  28359
Granville Medical CenterOxford, North Carolina  27565
Duke Health Raleigh HospitalRaleigh, North Carolina  27609
Person Memorial HospitalRoxboro, North Carolina  27573
Camino Medical Group - Treatment CenterMountain View, California  94040
CCOP - Kansas CityPrairie Village, Kansas  66208