Clinical trial · Interventional
S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
NCT00265785CI-TRIAL-00008389terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to poor accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- description
- pemetrexed
- interventionNames
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 0 - 3 years
- description
- Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Secondary outcomes (3)
- measure
- Progression-free Survival
- timeFrame
- 0 - 3 years
- description
- Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.