Phase 2
N=64
Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00508144 ↗Enrolled (actual)
64
Serious AEs
55.2%
Results posted
Feb 2017
Primary outcome: Primary: Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR) — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alimta (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR) |
3 | — |
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
Eligibility Criteria
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 /= 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)
- Absolute neutrophil count (ANC) >/= 1,500/µl
- Platelet >/= 100,000/µl
- ALT/AST: /=9.0 x 10^9/L
- Patient must not be pregnant or breastfeeding. Patients of childbearing potential agree to practice an effective contraceptive method for the duration of the study.
- 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.
- Men and women, aged >/=18 years.
Exclusion Criteria
- Prior treatment with pemetrexed therapy.
- 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.
Data sourced from ClinicalTrials.gov (NCT00508144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.