Articles and Resources
Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2010
First Received: March 11, 2010   Last Updated: November 23, 2010   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01085630

Purpose

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.


Condition Intervention Phase
Malignant Mesothelioma
Drug: pemetrexed disodium
Other: clinical observation
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Frequency of responses [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: April 2010
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Arm I: Experimental
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: pemetrexed disodium
Drug: pemetrexed disodium
Given IV
Arm II: No Intervention
Patients undergo observation until disease progression.
Intervention: Other: clinical observation
Other: clinical observation
Patients undergo observation

Detailed Description:

OBJECTIVES:

Primary

  • To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.

Secondary

  • To determine the overall survival of patients treated with this regimen versus observation.
  • To evaluate the frequency of responses in patients treated with this regimen.
  • To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium) and histologic subtype (epithelioid vs other).

  • Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.

Eligibility


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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:

    • Epithelial
    • Sarcomatoid
    • Mixed type
  • Disease not amenable to surgery
  • Must be enrolled on imaging protocol CALGB-580903
  • Complete response, partial response, or stable disease after completion of 4 courses of first-line chemotherapy comprising pemetrexed disodium AND cisplatin or carboplatin

    • Study therapy will begin ≥ 3 weeks and ≤ 6 weeks after the completion of course 4
  • No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium

PATIENT CHARACTERISTICS:

  • ECOG performance status of 0-1
  • Life expectancy ≥ 12 weeks
  • Granulocytes ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2 times ULN
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric illness that would prevent the patient from giving informed consent
  • No second malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless curatively treated with no evidence of active disease for ≥ 5 years
  • No medical conditions that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient including, but not limited to, the following:

    • Ongoing or active infection such as HIV positivity
    • Inability to take oral medications
    • Psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed

    • Prior intrapleural cytotoxic chemotherapy not considered systemic chemotherapy
  • Prior surgery allowed
  • Prior radiotherapy allowed

    • No concurrent palliative radiotherapy
  • No NSAIDS for 5 days before, during, or 2 days after study therapy
  • No concurrent hormones or other chemotherapeutic agents except for the following:

    • Steroids for adrenal failure
    • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic or premedication for pemetrexed disodium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085630

Locations
United States, Illinois
University of Chicago Cancer Research Center   (Recruiting)
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, Indiana
Michiana Hematology-Oncology, PC - Elkhart   (Recruiting)
Elkhart, Indiana, United States, 46514
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Elkhart Clinic, LLC   (Recruiting)
Elkhart, Indiana, United States, 46514-2098
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Elkhart General Hospital   (Recruiting)
Elkhart, Indiana, United States, 46515
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Howard Community Hospital   (Recruiting)
Kokomo, Indiana, United States, 46904
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Michiana Hematology Oncology PC - La Porte   (Recruiting)
La Porte, Indiana, United States, 46350
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Center for Cancer Therapy at LaPorte Hospital and Health Services   (Recruiting)
La Porte, Indiana, United States, 46350
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Saint Joseph Regional Medical Center   (Recruiting)
Mishawaka, Indiana, United States, 46545-1470
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Michiana Hematology-Oncology, PC - South Bend   (Recruiting)
Mishawaka, Indiana, United States, 46545-1470
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Michiana Hematology Oncology PC - Plymouth   (Recruiting)
Plymouth, Indiana, United States, 46563
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
CCOP - Northern Indiana CR Consortium   (Recruiting)
South Bend, Indiana, United States, 46601
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Memorial Hospital of South Bend   (Recruiting)
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend     800-284-7370        
South Bend Clinic   (Recruiting)
South Bend, Indiana, United States, 46617
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
United States, Michigan
Michiana Hematology Oncology PC - Niles   (Recruiting)
Niles, Michigan, United States, 49120
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Lakeside Cancer Specialists, PLLC   (Recruiting)
Saint Joseph, Michigan, United States, 49085
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
Lakeland Regional Cancer Care Center - St. Joseph   (Recruiting)
St. Joseph, Michigan, United States, 49085
Contact: Rafat H. Ansari, MD, FACP     574-234-5123        
United States, New York
CCOP - Hematology-Oncology Associates of Central New York   (Recruiting)
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD     315-472-7504        
United States, North Carolina
Wayne Memorial Hospital, Incorporated   (Recruiting)
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Kinston Medical Specialists   (Recruiting)
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD     252-559-2200ext.201        
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
at Ohio State University Comprehensive Cancer Center   (Recruiting)
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
United States, Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center   (Recruiting)
Kingsport, Tennessee, United States, 37662
Contact: Clinical Trials Office - Christine LaGuardia Phillips Cancer C     423-224-5593        
United States, Virginia
Danville Regional Medical Center   (Recruiting)
Danville, Virginia, United States, 24541
Contact: Clinical Trials Office - Danville Regional Medical Center     434-799-3753        
Southwest Virginia Regional Cancer Center at Wellmonth Health   (Recruiting)
Norton, Virginia, United States, 24273
Contact: Malcolm R. Mathews, MD     423-224-3150        
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Arkadiusz Dudek, MD Masonic Cancer Center, University of Minnesota

More Information


Additional Information:
No publications provided

Responsible Party: Cancer and Leukemia Group B ( Monica M. Bertagnolli )
ClinicalTrials.gov Identifier: NCT01085630     History of Changes
Other Study ID Numbers: CDR0000667496, CALGB-30901
Study First Received: March 11, 2010
Last Updated: November 23, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
epithelial mesothelioma
sarcomatous mesothelioma
advanced malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on December 08, 2010

Source: http://www.clinicaltrials.gov