Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer (NCT00508144) | Clinical Trial Compass
CompletedPhase 2
Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer
United States64 participantsStarted 2005-09
Plain-language summary
The goal of this clinical research study is to learn how effective the drug pemetrexed (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (PS) (inability to perform every day activities without difficulty).
Objectives:
Primary Objectives:
* PS = 2 cohort: Response
* PS = 3 cohort: Descriptive
Secondary Objectives:
* Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients
* Improved symptoms (both cohorts)
* Molecular Correlative studies (both cohorts)
* Overall survival
* Time to progression
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically proven Stage IIIB (T4 lesion due to malignant pleural or pericardial effusion) or Stage IV. Clinically significant pleural or peritoneal effusions should be drained prior to dosing.
✓. Zubrod PS 2 or PS 3
✓. Patients with asymptomatic brain metastases and no requirement for corticosteroids or anticonvulsants are eligible for this clinical trial.
✓. Measurable OR non-measurable disease documented by CT or MRI.
✓. Patients may have had \</=1 prior chemotherapy regimens but multiple prior biologic regimens. At least 4 weeks need to have elapsed since last chemotherapy or biologic therapy administration.
✓. Prior radiation therapy is permitted; however, at least two weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all associated toxicities at the time of registration. Measurable or non-measurable disease must be outside the previous radiation field OR patients with visible progression or new lesions within the radiation field are eligible.
✓. At least two weeks must have elapsed since surgery and patients must have recovered from all associated toxicities at the time of registration.
✓. Creatinine clearance \>/= 45 cc/min measured or calculated using the following formula: Calculated Creatinine Clearance = (140 - age) X WT (kg) X (0.85 if female)/72 X creatinine (mg/dl) Calculated Creatinine Clearance = (140 - age) X WT (kg) X (1.00 if male)/72 X creatinine (mg/dl)
Exclusion criteria
✕
What they're measuring
1
Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)
Timeframe: Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeks
✕. Patients planning to receive any other concomitant anticancer treatment including chemotherapy, radiation therapy, biologic agents or any other investigational drugs.
✕. Women who are pregnant or breastfeeding may not participate in this trial. All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study.
✕. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
✕. Inability and unwillingness to take folic acid or vitamin B12 supplementation.
✕. Inability to take corticosteroids.
✕. Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for \>/= 5 years.