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

SWOG Cancer Research Network

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: pemetrexed

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00265785

CDR0000456424

S0526 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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