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.
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
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
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There are 88 Locations for this study
Castro Valley California, 94546, United States
Castro Valley California, 94546, United States
Fremont California, 94538, United States
Martinez California, 94553, United States
Mountain View California, 94040, United States
Mountain View California, 94040, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Palo Alto California, 94301, United States
San Pablo California, 94806, United States
Fort Collins Colorado, 80528, United States
Hartford Connecticut, 06105, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Fort Lauderdale Florida, 33308, United States
Gainesville Florida, 32610, United States
Jupiter Florida, 33458, United States
Miami Beach Florida, 33140, United States
Chicago Illinois, 60637, United States
Bettendorf Iowa, 52722, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66213, United States
Prairie Village Kansas, 66208, United States
Augusta Maine, 04330, United States
Bangor Maine, 04401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21201, United States
Bethesda Maryland, 20889, United States
Elkton Maryland, 21921, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grand Blanc Michigan, 48439, United States
Grosse Pointe Woods Michigan, 48236, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Pascagoula Mississippi, 39581, United States
Columbia Missouri, 65203, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64118, United States
Kansas City Missouri, 64132, United States
Lee's Summit Missouri, 64086, United States
Liberty Missouri, 64068, United States
Saint Joseph Missouri, 64506, United States
Saint Joseph Missouri, 64507, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89106, United States
Concord New Hampshire, 03301, United States
Hooksett New Hampshire, 03106, United States
Laconia New Hampshire, 03246, United States
Manchester New Hampshire, 03103, United States
Voorhees New Jersey, 08043, United States
Buffalo New York, 14215, United States
East Syracuse New York, 13057, United States
Glens Falls New York, 12801, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28233, United States
Durham North Carolina, 27710, United States
Kinston North Carolina, 28501, United States
Lumberton North Carolina, 28359, United States
Oxford North Carolina, 27565, United States
Raleigh North Carolina, 27607, United States
Raleigh North Carolina, 27609, United States
Roxboro North Carolina, 27573, United States
Rutherfordton North Carolina, 28139, United States
Statesville North Carolina, 28677, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Canton Ohio, 44710, United States
Drexel Hill Pennsylvania, 19026, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Kingsport Tennessee, 37662, United States
Danville Virginia, 24541, United States
Norton Virginia, 24273, United States
Yakima Washington, 98902, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
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