En studie av ytterligere kjemoterapi etter kirurgi for personer med ondartet peritoneal mesothelioma
ICARuS II (intraperitoneal kjemoterapi etter cytoreduktiv kirurgi): En multisenter, randomisert fase II-forsøk med normoterm intraperitoneal kjemoterapi og intravenøs kjemoterapi etter cytoreduktiv kirurgi og hypertermisk intraperitoneal kjemoterapi for malignt peritonealt mesothelioma
The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Michael Offin, MD
- Telefonnummer: 646-608-3763
- E-post: offinm@mskcc.org
Studer Kontakt Backup
- Navn: Garrett Nash, MD
- Telefonnummer: 212-639-8668
- E-post: nashg@mskcc.org
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago (Data Collection Only)
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Ta kontakt med:
- Hedy Kindler, MD
- Telefonnummer: 773-702-1470
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Har ikke rekruttert ennå
- University of Michigan (Data Collection Only)
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Ta kontakt med:
- Donnele Daley, MD
- Telefonnummer: 734-647-8902
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Har ikke rekruttert ennå
- Washington University (Data Collection Only)
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Ta kontakt med:
- Trang Nguyen, MD
- Telefonnummer: 314-362-2280
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Nebraska
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Omaha, Nebraska, Forente stater, 68198-7680
- Har ikke rekruttert ennå
- University of Nebraska (Data collection only)
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Ta kontakt med:
- Jason Foster, MD
- Telefonnummer: 402-559-8941
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New Jersey
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Basking Ridge, New Jersey, Forente stater, 07920
- Rekruttering
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Ta kontakt med:
- Garrett Nash, MD, MPH
- Telefonnummer: 212-639-8668
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Middletown, New Jersey, Forente stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Ta kontakt med:
- Garrett Nash, MD
- Telefonnummer: 212-639-8668
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Montvale, New Jersey, Forente stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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Ta kontakt med:
- Garrett Nash, MD
- Telefonnummer: 212-639-8668
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New Brunswick, New Jersey, Forente stater, 08903
- Har ikke rekruttert ennå
- Rutgers University (Data Collection Only)
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Ta kontakt med:
- H. Richard Alexander, MD
- Telefonnummer: 732-235-6780
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New York
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Commack, New York, Forente stater, 11725
- Rekruttering
- Memorial Sloan Kettering Commack (Limited Protocol Activities)
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Ta kontakt med:
- Garrett Nash, MD
- Telefonnummer: 212-639-8668
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Harrison, New York, Forente stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Limited Protocol Activites)
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Ta kontakt med:
- Garrett Nash, MD
- Telefonnummer: 212-639-8668
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Ta kontakt med:
- Garrett Nash, MD
- Telefonnummer: 212-639-8668
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Uniondale, New York, Forente stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Ta kontakt med:
- Garrett Nash, MD
- Telefonnummer: 212-639-8668
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Rekruttering
- Allegheny Health Network (Data Collection Only)
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Ta kontakt med:
- Patrick Wagner, MD
- Telefonnummer: 833-246-7662
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient age 18 years or older, both sexes.
- Clinical diagnosis of MPM at enrolling institution.
- Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution.
- Complete or near-complete CRS achieved.
- Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
- ECOG performance status ≤ 1.
- Hematology: ANC ≥ 1,500/µl.
- Platelets > 75,000/µl.
- Adequate renal function: creatinine < 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml/min.
- Adequate hepatic function: bilirubin < 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL).
- Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study
- Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.
Exclusion Criteria:
- Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy/immunotherapy for peritoneal mesothelioma.
- Subjects who have previously received platinum-containing chemotherapy regimens.
- Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
- Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.
- High suspicion for extra-abdominal metastases.
- Women who are pregnant or lactating.
- Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.
- Uncontrolled hypertension defined as >140/90 and not cleared for surgery at the time of consent.
- New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study.
- Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.
- Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
- Any condition that would preclude the ability to deliver appropriate IP therapy.
- Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.
- Life expectancy < 12 weeks.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: IVC arm
Pemetrexed and cisplatin will be administered intravenously for a total of 4 to 6 cycles. Participants will receive 4 cycles, but can receive up to 6 cycles based on clinician discretion. Substitution with carboplatin allowed for pre-existing impairment of hearing, renal function, or neuropathy. |
Pemetrexed will be administered intravenously Cisplatin will be administered intravenously Possible substitution with carboplatin based on clinician discretion |
|
Aktiv komparator: NIPC arm
After completion of hyperthermic intraperitoneal chemotherapy/HIPEC, an intraperitoneal catheter with a subcutaneous reservoir will be inserted through the abdominal wall. When the participant's condition is considered stable by the physicians, the NIPC will be started. Pemetrexed and either cisplatin or carboplatin will be administered through the intraperitoneal port. |
Pemetrexed will be administered intravenously Cisplatin will be administered intravenously Possible substitution with carboplatin based on clinician discretion |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival
Tidsramme: up to 24 months
|
Progression Free Survival in the two treatment arms. |
up to 24 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Garrett Nash, MD, Memorial Sloan Kettering Cancer
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Lungesykdommer
- Neoplasmer, kjertel og epitel
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Adenom
- Neoplasmer, mesoteliale
- Pleurale neoplasmer
- Mesothelioma, ondartet
- Mesothelioma
- Aminosyrer, peptider og proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Guanin
- Hypoksantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sure
- Aminosyrer
- Aminosyrer, dikarboksyl
- Platinumforbindelser
- Pemetrexed
- Karboplatin
- Cisplatin
Andre studie-ID-numre
- 23-145
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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