Lung Cancer Clinical Trial

S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with stage III or stage IV non-small cell lung cancer.

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Full Description

OBJECTIVES:

Primary

Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar carcinoma treated with pemetrexed disodium.

Secondary

Evaluate the progression-free survival of patients treated with this drug.
Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the subset of patients with measurable disease treated with this drug using standard RECIST criteria and computer assisted image analysis.
Evaluate frequency and severity of toxicities in patients treated with this drug.
Perform molecular correlative studies on patient tissue to investigate potential predictors of efficacy. (This will not be completed as this study was closed due to poor accrual.)

OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib (yes vs no).

Patients receive pemetrexed disodium intravenous (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed bronchoalveolar carcinoma (BAC) or BAC variants such as adenocarcinoma with BAC features or BAC with invasive adenocarcinoma

Cytology specimens, such as bronchial brushings, washings, or fine needle aspiration specimens alone are not acceptable for diagnosis
Stage IV disease OR selected stage IIIB (T4 [secondary to malignant pleural effusion only], any N, M0) disease
Incompletely resected or unresectable disease
Pleural effusions, ascites, or laboratory parameters cannot be only evidence of disease
Measurable disease or nonmeasurable disease documented by CT scan
No known brain metastases

PATIENT CHARACTERISTICS:

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT and SGPT ≤ 2.5 times ULN ( ≤ 5 times ULN if due to liver metastases)
Alkaline phosphatase ≤ 2.5 times ULN ( ≤ 5 times ULN if due to bone metastases)
Creatinine clearance ≥ 45 mL/min OR creatinine ≤ 1.5 times ULN
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 75,000/mm³
Zubrod 0-2
No history of allergic reaction to compounds of similar chemical or biological composition as pemetrexed disodium
Must provide smoking history
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception
Able to swallow pills

PRIOR CONCURRENT THERAPY:

No more than 2 prior systemic therapies (including epidermal growth factor receptor inhibitor)
At least 28 days since prior systemic therapy
Patients treated with prior erlotinib or gefitinib must have shown progression since treatment
No prior pemetrexed disodium

At least 28 days since prior radiotherapy and recovered

Must have measurable or nonmeasurable disease outside previously irradiated area or a new lesion within previously irradiated area
At least 14 days since prior palliative radiotherapy and recovered
At least 28 days since prior thoracic or major surgery and recovered
No concurrent surgery
No other concurrent therapy (hormonal, biologic or radiotherapy) for this disease
No concurrent antiretroviral therapy
Patients should discontinue non-steroidal anti-inflammatory drugs (NSAIDs) with longer half lives (etodolac, ketordac, sulindac, naproxen, naproxen sodium, oxaprozin, nabumetone, diflunisal, salsalate, celecoxib, rofecoxib, valdecoxib, meloxicam, piroxicam) at least 5 days before and for 2 days following pemetrexed treatment

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

27

Study ID:

NCT00265785

Recruitment Status:

Terminated

Sponsor:

Southwest Oncology Group

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There are 93 Locations for this study

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Alaska Regional Hospital Cancer Center
Anchorage Alaska, 99508, United States
NEA Medical Center - Stadium Boulevard
Jonesboro Arkansas, 72401, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora Colorado, 80045, United States
Denver Health Medical Center
Denver Colorado, 80204, United States
Kapiolani Medical Center at Pali Momi
Aiea Hawaii, 96701, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu Hawaii, 96813, United States
Hawaii Medical Center - East
Honolulu Hawaii, 96817, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Maui Memorial Medical Center
Wailuku Hawaii, 96793, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Reid Hospital & Health Care Services
Richmond Indiana, 47374, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Cotton-O'Neil Cancer Center
Topeka Kansas, 66606, 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
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
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield Michigan, 48075, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Mary Rutan Hospital
Bellefontaine Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Middletown Regional Hospital
Franklin Ohio, 45005, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Mercy Medical Center
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Mount Carmel St. Ann's Cancer Center
Westerville Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington Ohio, 45177, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
Adventist Medical Center
Portland Oregon, 97216, United States
CCOP - Columbia River Oncology Program
Portland Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland Oregon, 97227, United States
Oregon Health and Science University Cancer Institute
Portland Oregon, 97239, United States
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston South Carolina, 29401, United States
CCOP - Greenville
Greenville South Carolina, 29615, 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
Danville Regional Medical Center
Danville Virginia, 24541, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Columbia Basin Hematology
Kennewick Washington, 99336, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Group Health Central Hospital
Seattle Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Southwest Washington Medical Center Cancer Center
Vancouver Washington, 98668, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

27

Study ID:

NCT00265785

Recruitment Status:

Terminated

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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