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NCT00265785

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

Last Updated: 2012-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Keywords

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bronchoalveolar cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemetrexed

pemetrexed

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

Pemetrexed 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.

Interventions

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pemetrexed

Intervention Type DRUG

Other Intervention Names

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Alimta

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Derick H. Lau, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Rachel E. Sanborn, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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Alaska Regional Hospital Cancer Center

Anchorage, Alaska, United States

Site Status

NEA Medical Center - Stadium Boulevard

Jonesboro, Arkansas, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Site Status