Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:April 2010

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Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

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.

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),
histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6).

- 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.

Inclusion Criteria:

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

- Epithelial

- Sarcomatoid

- Mixed type

- Histologically documented malignant pleural mesothelioma, epithelial,
sarcomatoid or mixed type, not amenable to surgical resection

- Prior treatment

- Currently receiving first-line treatment with pemetrexed + platinum; patients are to
be registered to Cancer and Leukemia Group B (CALGB) 30901 no later than the last day
of cycle 4 of first line therapy

- Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are
acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic
chemotherapy

- Prior surgical treatment is allowed

- Prior radiation therapy is allowed

- Non-pregnant and non-nursing; women of child bearing potential and men must agree
to use an appropriate method of birth control throughout their participation in
this study; appropriate methods of birth control include abstinence, oral
contraceptives, implantable hormonal contraceptives (Norplant), or double barrier
methods (diaphragm plus condom)

- RANDOMIZATION ELIGIBILITY CRITERIA

- Patients with complete response, partial response, or stable disease following 4,
5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or
carboplatin; a maximum of 6 cycles of chemotherapy may have been given

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Granulocytes >= 1,500/ul

- Platelet count >= 100,000/ul

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])
=< 2 x ULN

- Calculated creatinine clearance >= 45 ml/min

- 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 within 9 weeks following day 1 of cycle 4 of first-line
treatment

- 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 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
We found this trial at
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1 Hurley Plaza
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
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701 Doctors Dr
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1900 South Avenue
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1800 West Charleston Boulevard
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902 Savannah Road
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425 E River Pkwy # 754
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1600 Divisadero Street
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Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Newton, KS
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Normal, Illinois 61761
Phone: 309-451-8500
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Normal, IL
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1304 Franklin Avenue
Normal, Illinois 61761
309.454.1400
Phone: 309-454-1400
BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
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Normal, IL
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407 East Vernon Ave.
Normal, Illinois 61761
(309) 451-8500
Phone: 309-662-2102
Illinois CancerCare - Community Cancer Center At the Community Cancer Center, we are committed to...
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Normal, IL
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Oregon City, Oregon 97045
Phone: 503-650-6758
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Oregon City, OR
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Ottawa, Illinois 61350
Phone: 815-431-9270
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Ottawa, IL
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1100 East Norris Drive
Ottawa, Illinois 61350
(815) 433-3100
Phone: 815-433-3100
Community Hospital of Ottawa Ottawa Regional Hospital, an acute care medical facility, is located on...
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Ottawa, IL
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Parma, Ohio 44129
Phone: 440-743-4747
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Parma, OH
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1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
Phone: 316-262-4467
Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Parsons, KS
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603 S 13th St
Pekin, Illinois 61554
(309) 353-0512
Phone: 309-353-0512
Cancer Treatment Center at Pekin Hospital Since 1913, Pekin Hospital has been dedicated to improving...
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603 S 13th St
Pekin, Illinois 61554
(309) 353-0214
Phone: 309-353-0214
Illinois CancerCare - Pekin Illinois CancerCare is one of the largest private oncology and hematology...
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Pekin, IL
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Peoria, Illinois 61615
Phone: 309-243-3605
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Peoria, IL
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Peoria, Illinois 61615
Phone: 309-243-3000
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Peoria, IL
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