- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00024271
Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs directly into the tumor after surgery and combining them with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and radiation therapy in treating patients who have peritoneal cancer.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Determine the response rate, duration of response, and duration of survival of patients with peritoneal mesothelioma treated with surgery, intraperitoneal chemotherapy, and whole abdominal radiotherapy.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients undergo initial surgery, including total omentectomy and excision of gross disease. Approximately 3-4 weeks after surgery, patients receive intraperitoneal (IP) chemotherapy consisting of doxorubicin IP over 2 hours once weekly on weeks 1, 4, 7, and 10 and cisplatin IP and gemcitabine IP once weekly on weeks 2, 5, 8, and 11. Patients also receive interferon gamma IP once weekly on weeks 13-16.
At approximately week 18-20, patients undergo second-look surgery. Patients with no gross disease receive hyperthermia mitomycin IP and cisplatin IP over 90 minutes.
Approximately 2-4 weeks after second-look surgery, patients undergo radiotherapy 5 days a week for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant mesothelioma
- Measurable or evaluable disease
- Ineligible for other high-priority study
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- SWOG 0-2
- Karnofsky 60-100%
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 times normal
Renal:
- Creatinine clearance at least 45 mL/min
- BUN less than 1.5 times normal
- No significant calcium abnormalities
Cardiovascular:
- No symptomatic cardiovascular disease
- No New York Heart Association class II, III, or IV heart disease
- No congestive heart failure
- No angina pectoris
- No cardiac arrhythmia
- No uncontrolled hypertension
Other:
- No significant phosphate, electrolyte, or other metabolic abnormalities (e.g., metabolic acidosis)
- No uncontrolled psychiatric disorder or neurologic disease
- No seizure disorder
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer
- No other serious medical or psychiatric illness
- No uncontrolled serious infection
- No senility or emotional instability
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 2 prior chemotherapy regimens
- No more than 1 prior intraperitoneal chemotherapy regimen
- More than 6 weeks since prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
- Concurrent steroids for antiemesis, premedication, adrenal failure, or septic shock allowed
Radiotherapy:
- No prior abdominal, pelvic, or lower chest radiotherapy
Surgery:
- Prior surgical resection preceding disease recurrence allowed
- More than 1 week since prior surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Robert N. Taub, MD, PhD, Herbert Irving Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Adenom
- Neoplasmer, mesoteliale
- Pleurale neoplasmer
- Mesothelioma
- Mesothelioma, ondartet
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Alkyleringsmidler
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Gemcitabin
- Interferoner
- Cisplatin
- Interferon-gamma
- Doxorubicin
- Liposomal doksorubicin
- Mitomyciner
- Mitomycin
Andre studie-ID-numre
- CDR0000068907
- CPMC-IRB-13799
- NCI-G01-2015
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .