- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00077298
Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
A Randomized Phase II Study of Bevacizumab in Combination With Cetuximab Plus Irinotecan, or in Combination With Cetuximab Alone, in Irinotecan-Refractory Colorectal Cancer
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. Evaluate time to tumor progression in patients with irinotecan-refractory metastatic colorectal cancer treated with bevacizumab and cetuximab with or without irinotecan.
II. Evaluate objective response rate in patients treated with these regimens. III. Evaluate overall survival of patients treated with these regimens. IV. Evaluate safety, tolerability, and adverse event profiles of these regimens in these patients.
V. Correlate a panel of molecular markers (e.g., those involved in the epidermal growth factor receptor signaling pathway, angiogenic pathway, and irinotecan metabolism) with clinical outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 vs 1), and albumin (> 3.0 g/dL vs ≤ 3.0 g/dL). Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36; bevacizumab IV over 30-90 minutes on days 1*, 15, and 29 OR on days 1 and 22; and irinotecan IV over 30-90 minutes (at the same dose and schedule that the patient previously received) beginning on day 1.
ARM B: Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1*, 15, and 29.
NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses.
In both arms, courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
New York
-
New York, New York, Vereinigte Staaten, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Histologically or cytologically confirmed colorectal cancer
- Metastatic disease by diagnostic imaging studies
Measurable disease
- At least 1 unidimensionally measurable lesion with minimum lesion size at least twice the slice thickness of the imaging study used
Refractory to irinotecan, evidenced by clinical documentation
- Received at least 1 prior irinotecan-containing chemotherapy regimen for metastatic disease and progressed during or within 6 weeks after completion of therapy
Must have received prior irinotecan according to 1 of the following schedules:
- Weekly administration with a starting dose of 100-125 mg/m^2
- Biweekly administration (every other week) with a starting dose of approximately 180 mg/m^2
- Once every three weekly administration with a starting dose of 300-350 mg/m^2
- No known brain metastases
- No prior primary CNS tumors
- Performance status - ECOG 0-1
- Performance status - Karnofsky 80-100%
- More than 3 months
- WBC >= 3,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9 g/dL
- No bleeding diathesis or coagulopathy
- Bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal (ULN) (5 times ULN in the presence of known liver metastases)
- INR < 1.5 (for patients receiving warfarin)
- Creatinine =< ULN
- Creatinine clearance ≥ 60 mL/min
- No proteinuria
- No prior stroke
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No uncontrolled hypertension
- No clinically significant cardiac arrhythmia
None of the following arterial thromboembolic events within the past 6 months:
- Myocardial infarction
- Cerebrovascular accident
- Transient ischemic attack
- Unstable angina
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No significant traumatic injury within the past 28 days
- No grade 3 or greater neurotoxicity
- No uncontrolled seizures
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents
- No prior irinotecan intolerance
- No ongoing or active infection requiring parenteral antibiotics
- No serious nonhealing active wound, ulcer, or bone fracture
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness that would preclude study participation
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No prior cetuximab
- No other prior epidermal growth factor receptor-directed therapy
No prior anticancer murine or chimeric monoclonal antibody therapy
- Prior humanized monoclonal antibody therapy allowed
- No prior bevacizumab
- No other prior vascular endothelial growth factor-targeted therapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- More than 4 weeks since prior radiotherapy
- More than 28 days since prior major surgical procedure or open biopsy
- Recovered from all prior therapy
- Any number of prior standard or investigational regimens allowed
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No recent or concurrent thrombolytic agents
- No recent or concurrent full-dose warfarin except as required to maintain patency of preexisting, permanent indwelling IV catheters
No concurrent therapeutic heparin
- Concurrent prophylactic low-molecular weight heparin allowed
- No concurrent chronic daily aspirin (> 325 mg/day)
- No concurrent nonsteroidal anti-inflammatory medications known to inhibit platelet function
- No concurrent combination antiretroviral therapy for HIV-positive patients
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Arm A (cetuximab, bevacizumab, irinotecan)I
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36; bevacizumab IV over 30-90 minutes on days 1*, 15, and 29 OR on days 1 and 22; and irinotecan IV over 30-90 minutes (at the same dose and schedule that the patient previously received) beginning on day 1. NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses. |
Korrelative Studien
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
|
Experimental: Arm B (cetuximab and bevacizumab)
Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1*, 15, and 29. NOTE: *Bevacizumab is given on day 2 (instead of day 1) of course 1, and is given on day 1 of subsequent courses. |
Korrelative Studien
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Time to tumor progression
Zeitfenster: Date of randomization to the date of either documentation of disease progression, or death, assessed up to 3 years
|
Date of randomization to the date of either documentation of disease progression, or death, assessed up to 3 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Objective response rate
Zeitfenster: Up to 3 years
|
Up to 3 years
|
|
Overall survival
Zeitfenster: Up to 3 years
|
Survival probabilities will be computed using Kaplan-Meier methods and compared using the log-rank test.
|
Up to 3 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Leonard Saltz, Memorial Sloan Kettering Cancer Center
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 (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Pathologische Prozesse
- Neubildungen
- Neubildungen nach Standort
- Krankheitsattribute
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Kolorektale Neubildungen
- Wiederauftreten
- Rektale Neoplasien
- Darmneoplasmen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Immunologische Faktoren
- Topoisomerase-Inhibitoren
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Topoisomerase I-Inhibitoren
- Antikörper
- Immunglobuline
- Bevacizumab
- Irinotecan
- Antikörper, monoklonal
- Antineoplastische Mittel, immunologische
- Cetuximab
Andere Studien-ID-Nummern
- NCI-2012-01445 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- N01CM17101 (US NIH Stipendium/Vertrag)
- 03-135 (Andere Kennung: Memorial Sloan-Kettering Cancer Center)
- N01CM17105 (US NIH Stipendium/Vertrag)
- N01CM17102 (US NIH Stipendium/Vertrag)
- N01CM17103 (US NIH Stipendium/Vertrag)
- MSKCC-03135
- NCI-6444
- CDR0000350086
- 6444 (Andere Kennung: CTEP)
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