Lung Cancer Clinical Trial

Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, 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. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

View Full Description

Full Description

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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

78

Study ID:

NCT00553462

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 88 Locations for this study

See Locations Near You

East Bay Radiation Oncology Center
Castro Valley California, 94546, United States
Valley Medical Oncology Consultants - Castro Valley
Castro Valley California, 94546, United States
Valley Medical Oncology
Fremont California, 94538, United States
Contra Costa Regional Medical Center
Martinez California, 94553, United States
Camino Medical Group - Treatment Center
Mountain View California, 94040, United States
El Camino Hospital Cancer Center
Mountain View California, 94040, United States
Highland General Hospital
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Bay Area Breast Surgeons, Incorporated
Oakland California, 94609, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Larry G Strieff MD Medical Corporation
Oakland California, 94609, United States
Tom K Lee, Incorporated
Oakland California, 94609, United States
Palo Alto Medical Foundation
Palo Alto California, 94301, United States
Doctors Medical Center - San Pablo Campus
San Pablo California, 94806, United States
Poudre Valley Radiation Oncology
Fort Collins Colorado, 80528, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter Florida, 33458, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Saint Luke's Hospital - South
Overland Park Kansas, 66213, United States
CCOP - Kansas City
Prairie Village Kansas, 66208, United States
Harold Alfond Center for Cancer Care
Augusta Maine, 04330, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor Maine, 04401, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Veterans Affairs Medical Center - Baltimore
Baltimore Maryland, 21201, United States
National Naval Medical Center
Bethesda Maryland, 20889, United States
Union Hospital of Cecil County
Elkton Maryland, 21921, United States
Boston University Cancer Research Center
Boston Massachusetts, 02118, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Genesys Regional Medical Center
Grand Blanc Michigan, 48439, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Memorial Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
St. Mary Mercy Hospital
Livonia Michigan, 48154, United States
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
Regional Cancer Center at Singing River Hospital
Pascagoula Mississippi, 39581, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City Missouri, 64111, United States
St. Joseph Medical Center
Kansas City Missouri, 64114, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Parvin Radiation Oncology
Kansas City Missouri, 64116, United States
Heartland Hematology Oncology Associates, Incorporated
Kansas City Missouri, 64118, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Hospital
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Joseph Oncology, Incorporated
Saint Joseph Missouri, 64507, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord New Hampshire, 03301, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett New Hampshire, 03106, United States
Lakes Region General Hospital
Laconia New Hampshire, 03246, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester New Hampshire, 03103, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse New York, 13057, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls New York, 12801, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Kinston Medical Specialists
Kinston North Carolina, 28501, United States
Southeastern Regional Medical Center
Lumberton North Carolina, 28359, United States
Granville Medical Center
Oxford North Carolina, 27565, United States
Rex Cancer Center at Rex Hospital
Raleigh North Carolina, 27607, United States
Duke Health Raleigh Hospital
Raleigh North Carolina, 27609, United States
Person Memorial Hospital
Roxboro North Carolina, 27573, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Iredell Memorial Hospital
Statesville North Carolina, 28677, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Barberton Citizens Hospital
Barberton Ohio, 44203, United States
Aultman Cancer Center at Aultman Hospital
Canton Ohio, 44710, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill Pennsylvania, 19026, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport Tennessee, 37662, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
Norton Virginia, 24273, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima Washington, 98902, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee Wisconsin, 53295, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

78

Study ID:

NCT00553462

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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