- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00030563
Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any remaining tumor cells.
PURPOSE: Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
OBJECTIVES:
- Determine the disease-free survival in patients with hepatic metastases from primary colorectal carcinoma treated with surgical resection with or without radiofrequency ablation followed by irinotecan.
- Determine the overall survival in patients treated with this regimen.
- Determine the treatment-related toxicity of this regimen in these patients.
- Correlate the measurement of molecular markers with clinical outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment with radiofrequency ablation in addition to resection (yes vs no).
Patients undergo surgical resection with or without radiofrequency ablation. Beginning 4-8 weeks after surgery, patients receive irinotecan IV over 90 minutes on day 1. Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Studientyp
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44106-5065
- Ireland Cancer Center
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Washington
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Seattle, Washington, Vereinigte Staaten, 98195
- University of Washington School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
- Histologically confirmed primary colorectal adenocarcinoma
Hepatic metastases that are considered completely resectable
- No more than 4 metastases by dual phase CT scan OR
Hepatic metastases that are not completely resectable but are amenable to complete destruction with resection and radiofrequency ablation
- More than 4 metastases allowed if all disease can be resected or destroyed in situ with radiofrequency ablation
- No extrahepatic disease in any location
- No recurrent or second primary colorectal cancer by colonoscopy within the past year
- Received prior adjuvant chemotherapy with a fluorouracil-based regimen with the last dose at least 1 month prior to surgery
- No prior radiofrequency ablation with residual viable intrahepatic disease by CT scan
- No plans to be treated with radiofrequency ablation alone without surgical resection
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 5 times ULN
- No Gilbert's disease or other known defect in hepatic conjugation or glucuronidation
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No myocardial infarction within the past 6 months
- No congestive heart failure requiring therapy
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 30 days after study
- No other malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix
- No active serious infection
- No other serious underlying medical condition or severe concurrent disease that would preclude study participation
- No dementia, significantly altered mental status, or psychiatric illness that would preclude study participation
- No known hypersensitivity to irinotecan
- No known infection with HIV or AIDS
- No uncontrolled diabetes mellitus
- No history of seizures
- No drug or alcohol abuse within the past year
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior irinotecan
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to more than 30% of bone marrow
- No prior radiotherapy to the liver
- At least 3 months since prior radiotherapy to the pelvis or other areas
Surgery:
- See Disease Characteristics
- No prior resection of hepatic metastases (wedge biopsy allowed)
Other:
- No concurrent phenytoin, phenobarbital, or other antiepileptic medication
- No concurrent enrollment in other investigational drug trials
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Kevin G. Billingsley, MD, University of Washington
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Kolorektale Neubildungen
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Topoisomerase-Inhibitoren
- Topoisomerase I-Inhibitoren
- Irinotecan
Andere Studien-ID-Nummern
- 18033
- UWASH-1200
- CWRU-040106
- UWASH-440E-ONC-0020-250
- NCI-G01-2045
- CWRU-UWMC-1200
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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