Mesothelioma Articles and Resources - Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy

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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