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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 Center Bethesda, Maryland  20889
University of Chicago Cancer Research Center Chicago, Illinois  60637
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Hurley Medical Center Flint, Michigan  48503
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Baltimore Baltimore, Maryland  21201
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Iredell Memorial Hospital Statesville, North Carolina  28677
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Danville Regional Medical Center Danville, Virginia  24541
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington  98902
Poudre Valley Radiation Oncology Fort Collins, Colorado  80528
Highland General Hospital Oakland, California  94602
Palo Alto Medical Foundation Palo Alto, California  94301
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Menorah Medical Center Overland Park, Kansas  66209
Saint Luke's Hospital - South Overland Park, Kansas  66213
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
St. Joseph Medical Center Kansas City, Missouri  64114
Heartland Hematology Oncology Associates, Incorporated Kansas City, Missouri  64118
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Elliot Regional Cancer Center at Elliot Hospital Manchester, New Hampshire  03103
Rex Cancer Center at Rex Hospital Raleigh, North Carolina  27607
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Harold Alfond Center for Cancer Care Augusta, Maine  04330
Union Hospital of Cecil County Elkton MD, Maryland  21921
Kinston Medical Specialists Kinston, North Carolina  28501
Lakes Region General Hospital Laconia, New Hampshire  03246
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
Boston University Cancer Research Center Boston, Massachusetts  02118
Parvin Radiation Oncology Kansas City, Missouri  64116
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
El Camino Hospital Cancer Center Mountain View, California  94040
Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
Bay Area Breast Surgeons, Incorporated Oakland, California  94609
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
AnMed Cancer Center Anderson, South Carolina  29621
Veterans Affairs Medical Center - Milwaukee Milwaukee, Wisconsin  53295
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Southeastern Regional Medical Center Lumberton, North Carolina  28359
Granville Medical Center Oxford, North Carolina  27565
Duke Health Raleigh Hospital Raleigh, North Carolina  27609
Person Memorial Hospital Roxboro, North Carolina  27573
Camino Medical Group - Treatment Center Mountain View, California  94040
CCOP - Kansas City Prairie Village, Kansas  66208