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. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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- Start Date: April 2010
- Primary Completion Date: January 2012
- Completion Date:
- Last Updated Date: October 19, 2010
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085630.
For More Information On Participating In This Clinical Trial
- University of Chicago Cancer Research Center
Chicago, Illinois 60637
773-834-7424 - CCOP Hematology-Oncology Associates of Central New York
Goldsboro, North Carolina 27534
Contact: James N. Atkins, M.D.
919-580-0000 - Kinston Medical Specialists
Kinston, North Carolina 27534
Contact: James N. Atkins, M.D.
919-580-0000 - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at OSU
Columbus, Ohio 43210
866-627-7616 - Christine LaGuardia Phillips Cancer Center
Kingsport, Tennessee 37662
423-224-5593 - Danville Regional Medical Center
Danville, Virginia 24541
434-799-3753 - Southwest Virginia Regional Cancer Center
Norton, Virginia 24273
Contact: Malcolm R. Mathews, M.D.
423-224-3150
Find More Information on
- Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite
- Detecting Abnormal Cells in Patients Surgery for Lung Cancer
- Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
- Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
- Study of Patients With Malignant Pleural Mesothelioma Cancers
Call 1-800-966-2244 to find out how we can help receive compensation for you and your family or fill out this short form to find a mesothelioma lawyer in your area.