Status:
TERMINATED
S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed 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 survi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00265785
Start Date
July 1 2006
End Date
July 1 2011
Last Update
November 1 2012
Active Locations (112)
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1
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
2
NEA Medical Center - Stadium Boulevard
Jonesboro, Arkansas, United States, 72401
3
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
4
University of California Davis Cancer Center
Sacramento, California, United States, 95817