CompletedPhase 2NCT00508144
Official study title

Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAlimta

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 13, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: Alimta
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. 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. 2. Zubrod PS 2 or PS 3 3. Patients with asymptomatic brain metastases and no requirement for corticosteroids or anticonvulsants are eligible for this clinical trial. 4. Measurable OR non-measurable disease documented by CT or MRI. 5. 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. 6. 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. 7. At least two weeks must have elapsed since surgery and patients must have recovered from all associated toxicities at the time of registration. 8. 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) 9. Absolute neutrophil count (ANC) \>/= 1,500/µl 10. Platelet \>/= 100,000/µl 11. ALT/AST: \</=3.0 x upper limit of normal (ULN) except in known hepatic metastasis wherein may be \</= 5 x ULN 12. Bilirubin: \</=1.5 x ULN 13. Hemoglobin: \>/=9.0 x 10\^9/L 14. Patient must not be pregnant or breastfeeding. Patients of childbearing potential agree to practice an effective contraceptive method for the duration of the study. 15. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. 16. Men and women, aged \>/=18 years.

Reasons someone may not be able to joinExclusion criteria

1. Prior treatment with pemetrexed therapy. 2. Patients planning to receive any other concomitant anticancer treatment including chemotherapy, radiation therapy, biologic agents or any other investigational drugs. 3. 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. 4. 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). 5. Inability and unwillingness to take folic acid or vitamin B12 supplementation. 6. Inability to take corticosteroids. 7. 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2017. Always confirm current availability with the study team.

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