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

NCT00508144 | Completed Phase 2 Results

• 2 other identifiers: 2004-0957NCI-2012-01581
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Lung Cancer; NSCLC; Malignant pleural effusion; Pericardial effusion; Pemetrexed; Alimta; LY231514; Poor Performance Status; Asymptomatic Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)

  Complete Response (CR): Complete disappearance of all measurable \& non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers \& other abnormal lab values. Partial Response (PR): Applies only to those with at least one measurable lesion. \>/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline. Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician. Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles).

  Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeks

Study Arms (1)

Alimta

EXPERIMENTAL

Alimta 500 mg/m\^2 by vein Once Over 10 Minutes Every 3 Weeks.

Drug: Alimta

Interventions

Alimta DRUG

500 mg/m\^2 by vein Once Over 10 Minutes Every 3 Weeks

Also known as: Pemetrexed, LY231514, MTA, Multitargeted Antifolate, NSC-698037

Alimta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Absolute neutrophil count (ANC) \>/= 1,500/µl
• Platelet \>/= 100,000/µl
• ALT/AST: \</=3.0 x upper limit of normal (ULN) except in known hepatic metastasis wherein may be \</= 5 x ULN
• Bilirubin: \</=1.5 x ULN
• Hemoglobin: \>/=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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pericardial Effusion

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Pleural Effusion; Pleural Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Ralph Zinner, MD/Thoracic & Head and Neck Medicine
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Ralph Zinner, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 13, 2017
• Results First Posted: February 13, 2017

Record last verified: 2016-12

Locations

US (1)