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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508144
First received: July 26, 2007
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 (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

Condition Intervention Phase
Lung Cancer
Drug: Alimta
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Agent Alimta in Poor Performance Status in Patients With Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Objective Response Rate (OR) [ Time Frame: Evaluated for symptoms 1-2 times per week while receiving treatment and then 2 weeks after stopping study treatment until 6 months after stopping treatment have physical exams, routine blood and urine tests, and a chest x-ray. ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2005
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alimta
Alimta 500 mg/m^2 by vein Once Over 10 Minutes Every 3 Weeks.
Drug: Alimta
500 mg/m^2 by vein Once Over 10 Minutes Every 3 Weeks
Other Names:
  • Pemetrexed
  • LY231514
  • MTA
  • Multitargeted Antifolate
  • NSC-698037

Detailed Description:

Pemetrexed is designed to block enzymes in the body that are important for tumor growth. Pemetrexed is commercially approved for the treatment of NSCLC but not for poor performance status patients.

If you are found to be eligible to take part in this study, you will receive pemetrexed once every 3 weeks through a needle in your vein over about 10 minutes. Every 3 weeks is considered 1 treatment cycle. Once the treatment has started, you will return to the clinic before every treatment cycle. At these visits, you will have a physical exam, a performance status evaluation, and routine blood (about 3-4 teaspoons) and urine tests. You will have a chest x-ray and you will be asked to complete a questionnaire about how you are feeling. You will also have a CT or MRI scan after Cycle 1 and every odd cycle from then on.

You are required to take folic acid by mouth every day for 5 days before the first dose of pemetrexed and continuing until 3 weeks after your last dose of pemetrexed. You will also receive an injection of vitamin B12 into your muscle before your first dose of pemetrexed. The vitamin B12 injection will be repeated every 9 weeks until 3 weeks after your last dose of pemetrexed.

You will also to take a few low-dose steroid (dexamethasone) tablets twice a day before treatment, the day of treatment, and the day after each treatment. These will be taken to decrease the risk of rash and nausea caused by pemetrexed.

You may continue treatment with pemetrexed until your tumor grows or an unacceptable side effect occurs. You will be evaluated for symptoms 1-2 times per week while you are receiving treatment and then 2 weeks after stopping study treatment until 6 months after stopping treatment.

When you stop treatment on this study, you will have a physical exam, routine blood (3-4 teaspoons) and urine tests, and a chest x-ray. The study doctor may ask you to visit UTMDACC or be contacted by phone for follow-up on how you are doing.

This is an investigational study. The FDA has approved pemetrexed for the treatment of advanced NSCLC after earlier treatment with chemotherapy, and for the treatment for malignant mesothelioma in combination with cisplatin. About 70 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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. ANC >/= 1,500/µl
  10. Platelet >/= 100,000/µl
  11. ALT/AST: </=3.0 x 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.

Exclusion 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508144

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eli Lilly and Company
Investigators
Principal Investigator: Ralph Zinner, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508144     History of Changes
Other Study ID Numbers: 2004-0957
Study First Received: July 26, 2007
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Lung Cancer
NSCLC
Malignant pleural effusion
Pericardial effusion
Pemetrexed
Alimta
LY231514
Poor Performance Status
Asymptomatic Brain Metastases

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Folic Acid Antagonists
Pemetrexed
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014