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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 93 Locations for this study
Anchorage Alaska, 99508, United States
Jonesboro Arkansas, 72401, United States
Los Angeles California, 90089, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80204, United States
Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Wailuku Hawaii, 96793, United States
Beech Grove Indiana, 46107, United States
Richmond Indiana, 47374, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66606, 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
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
Southfield Michigan, 48075, United States
Warren Michigan, 48093, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Goldsboro North Carolina, 27534, United States
Rutherfordton North Carolina, 28139, United States
Bellefontaine Ohio, 43311, United States
Chillicothe Ohio, 45601, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Delaware Ohio, 43015, United States
Findlay Ohio, 45840, United States
Franklin Ohio, 45005, United States
Kettering Ohio, 45429, United States
Lancaster Ohio, 43130, United States
Marietta Ohio, 45750, United States
Newark Ohio, 43055, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Troy Ohio, 45373, United States
Westerville Ohio, 43081, United States
Wilmington Ohio, 45177, United States
Xenia Ohio, 45385, United States
Zanesville Ohio, 43701, United States
Gresham Oregon, 97030, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97216, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Tualatin Oregon, 97062, United States
Anderson South Carolina, 29621, United States
Charleston South Carolina, 29401, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Danville Virginia, 24541, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Spokane Washington, 99202, United States
Vancouver Washington, 98668, United States
Sheridan Wyoming, 82801, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.