Malignant MesotheliomaPhase 2NCT01085630
Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
A Phase 2 study testing pemetrexed disodium and clinical observation in people with Malignant Mesothelioma, run by Alliance for Clinical Trials in Oncology at 145 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- pemetrexed disodium and clinical observation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 145 sitesUnited States
- Study dates
- Apr 2010to 1 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 52Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
145 sites in 1 country.
145 sites in 1 country
United States145 sites
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
Barberton Citizens Hospital
Barberton, Ohio, 44203
Ochsner Health Center - Bluebonnet
Baton Rouge, Louisiana, 70809
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, 44122
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701
St. Joseph Medical Center
Bloomington, Illinois, 61701
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
St. Joseph's Medical Center
Brainerd, Minnesota, 56401
Illinois CancerCare - Canton
Canton, Illinois, 61520
Illinois CancerCare - Carthage
Carthage, Illinois, 62321
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, 29401
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
Ochsner Health Center - Covington
Covington, Louisiana, 70433
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001
Danville Regional Medical Center
Danville, Virginia, 24541
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801
Essentia Health - Duluth Clinic
Duluth, Minnesota, 55805-1983
CCOP - Duluth
Duluth, Minnesota, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, 55805
Duke Cancer Institute
Durham, North Carolina, 27710
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Union Hospital of Cecil County
Elkton, Maryland, 21921
Eureka Community Hospital
Eureka, Illinois, 61530
Illinois CancerCare - Eureka
Eureka, Illinois, 61530
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Galesburg Clinic, PC
Galesburg, Illinois, 61401
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Illinois CancerCare - Havana
Havana, Illinois, 62644
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, 18201
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
Cleveland Clinic Cancer Center
Independence, Ohio, 44131
Foote Memorial Hospital
Jackson, Michigan, 49201
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068
Kinston Medical Specialists
Kinston, North Carolina, 28501
Howard Community Hospital
Kokomo, Indiana, 46904
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601
La Grange Memorial Hospital
La Grange, Illinois, 60525
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901
St. Mary Mercy Hospital
Livonia, Michigan, 48154
Illinois CancerCare - Macomb
Macomb, Illinois, 61455
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, 67460
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470
Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462
OSF Holy Family Medical Center
Monmouth, Illinois, 61462
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, 06050
New Orleans Cancer Institute at Memorial Medical Center
New Orleans, Louisiana, 70115
CCOP - Ochsner
New Orleans, Louisiana, 70121
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Providence Newberg Medical Center
Newberg, Oregon, 97132
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114
BroMenn Regional Medical Center
Normal, Illinois, 61761
Community Cancer Center
Normal, Illinois, 61761
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761
Willamette Falls Hospital
Oregon City, Oregon, 97045
Community Hospital of Ottawa
Ottawa, Illinois, 61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350
Parma Community General Hospital
Parma, Ohio, 44129
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554
Illinois CancerCare - Pekin
Pekin, Illinois, 61603
Proctor Hospital
Peoria, Illinois, 61614
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Illinois CancerCare - Peru
Peru, Illinois, 61354
Illinois Valley Community Hospital
Peru, Illinois, 61354
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124
Illinois CancerCare - Princeton
Princeton, Illinois, 61356
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, 61362
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801
Iredell Memorial Hospital
Statesville, North Carolina, 28677
Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio, 44136
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98664
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, 98684
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
St. John Macomb Hospital
Warren, Michigan, 48093
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214
CCOP - Wichita
Wichita, Kansas, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156
Cleveland Clinic - Wooster
Wooster, Ohio, 44691
About this study
Official title: 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.
Read the 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), 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.
- Conditions
- Malignant Mesothelioma
- Being tested
- pemetrexed disodium, clinical observation
- Keywords
- epithelial mesothelioma, sarcomatous mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma
- Medical subject headings
- Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed disodiumDrug
Also called 150399-23-8
Given IV
clinical observationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: pemetrexed disodium |
| Arm II | Active comparator | Patients undergo observation until disease progression. Receives: Other: clinical observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Measured: Baseline up to 3 years
Secondary outcomes (3)
Overall Survival
Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Measured: Baseline up to 3 years
Response Rate
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test
Measured: Up to 3 years
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2017
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arkadiusz Dudek, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085630
- Sponsor's protocol ID
- CALGB-30901
- Other IDs
- CALGB-30901, U10CA180821, U10CA031946, CDR0000667496
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2010
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01085630
- Acronym / sponsor ID
- CALGB-30901
- Conditions
- Malignant Mesothelioma
- Keywords
- epithelial mesothelioma, sarcomatous mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2010 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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), 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: pemetrexed disodiumPatients 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 | Active comparator | Other: clinical observationPatients undergo observation until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (52 listed)
- Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexed disodiumAlso: 150399-23-8Given IV | Drug | Arm I |
| clinical observation | Other | Arm II |
Primary outcome
Progression-free Survival
Time frame: Baseline up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
3 secondary outcomes
Overall Survival
Time frame: Baseline up to 3 years
Response Rate
Time frame: Up to 3 years
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
Time frame: Baseline up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arkadiusz Dudek, MD study chair
Masonic Cancer Center, University of Minnesota
145 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed disodium and clinical observation in people with Malignant Mesothelioma, run by Alliance for Clinical Trials in Oncology at 145 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 52 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 145 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: Baseline up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.