- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00423930
Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
A Phase II Study of Radiotherapy (IMRT) + Cisplatin + Bevacizumab for Patients With Stage III/IV Head and Neck Cancers
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin and bevacizumab together with intensity-modulated radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and bevacizumab together with intensity-modulated radiation therapy works in treating patients with stage III or stage IV head and neck cancer.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
OBJECTIVES:
Primary
- Determine the 2-year progression-free survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with chemoradiotherapy comprising cisplatin, bevacizumab, and intensity-modulated radiotherapy.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the median overall survival of patients treated with this regimen.
OUTLINE:
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 1, 2, 22, 23, 43, and 44 and bevacizumab IV over 30-90 minutes on days 1, 22, and 43. Patients also undergo intensity-modulated radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.
Between 3-4 months after completion of chemoradiotherapy, patients undergo evaluation. Patients with clinical evidence of residual, progressive, or persistent disease may be eligible to undergo neck surgery at the discretion of their physician.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10065
- Memorial Sloan-Kettering Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Stage III/IV HNSCC without distant metastasis, previously untreated. Patients with stage II squamous cell carcinoma of the hypopharynx will also be eligible.
- Adequate renal function, with serum creatinine ≤ 1.5 mg/dL. Patients with serum creatinine > 1.5 mg/dL may be eligible if calculated creatinine clearance ≥ 55 ml/min by Cockcroft and Gault equation (or 24-hour urine collection).
- Age ≥ 18 years
- Karnofsky performance status ≥70%
- Adequate bone marrow function: absolute neutrophil count ≥ 1,500/μl, platelets ≥ 100,000/μl, hemoglobin ≥ 9 gm/dl
- Adequate hepatic function: Total bilirubin ≤ 1.5 X UNL (patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X UNL), aspartate aminotransferase (AST) ≤ 2.5 X UNL, alanine aminotransferase (ALT) ≤ 2.5 X UNL, alkaline phosphatase ≤ 2.5 X UNL.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior chemotherapy or radiation therapy for HNSCC
- Prior treatment with bevacizumab or other agents specifically targeting VEGF
- Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.
- Patients with nasopharyngeal carcinoma
- Patients who will receive amifostine as part of the radiation treatment plan
- Patients with skin breakdown/ulceration (CTCAE version 3.0, grade 2 or higher).
- Patients with hearing loss requiring hearing aid or intervention (i.e. interfering in a clinical significant way with activities of daily living).
- Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living).
- History of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI) within the last 3 years.
- Urine protein: creatinine (UPC) ratio ≥ 1.0 at screening. A random urine sample is collected. Total protein (mg/dL) and spot creatinine (mg/dL) are ordered for this sample. The UPC ratio is calculated from the results of these tests.
- International normalized ratio (INR) > 1.5 or activated partial thromboplastin time (aPTT) > 1.5 X upper limits of normal (UNL),
- Current use of warfarin, current use of heparin or low-molecular weight heparin, chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal antiinflammatory medications known to inhibit platelet function. Treatment with dipyramidole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and or cilostazol (Pletal) is not allowed.
- Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon of more) within 1 month prior to Day 1 protocol treatment will be excluded from this trial. Patients with incidental blood mixed with phlegm are not excluded.
- Esophageal varices, non-healing ulcer, wound, or bone fracture are exclusion criteria. However, patients with skin breakdown overlying malignant neck lymphadenopathy may be eligible, at the discretion of the investigator.
- Anatomic lesion that increases the risk of serious hemorrhage, such as encasement or invasion of major blood vessels by primary tumor and/or by involved lymph nodes
- Blood pressure of > 150/100 mmHg
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Clinically significant peripheral vascular disease
- History of bleeding diathesis or hemorrhagic disorder, or coagulopathy.
- Major surgical procedure or significant traumatic injury within 28 days prior to treatment with bevacizumab
- Core biopsy within 15 days prior to treatment with bevacizumab.
- Minor surgical procedures such as fine needle aspirations or placement of percutaneous gastrostomy tube (PEG) less than 7 days prior to treatment with bevacizumab
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior enrollment.
- Inability to comply with study and/or follow-up procedures
- Women who are pregnant or lactating
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: IMRT + cisplatin + bevacizumab
This is a single-institution phase II study.
The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Progression-free Survival at 2 Years
Zeitfenster: Percentage of Participants Experiencing Progression-free Survival at 2 Years
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Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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Percentage of Participants Experiencing Progression-free Survival at 2 Years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Overall Survival Rate: Percentage of Participants Who Survived
Zeitfenster: 2 years
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2 years
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: David G. Pfister, MD, Memorial Sloan Kettering Cancer Center
Publikationen und hilfreiche Links
Nützliche Links
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
- Plattenepithelkarzinom im Stadium III der Lippe und Mundhöhle
- Plattenepithelkarzinom im Stadium IV der Lippen und der Mundhöhle
- Plattenepithelkarzinom des Oropharynx im Stadium III
- Plattenepithelkarzinom des Oropharynx im Stadium IV
- Plattenepithelkarzinom im Stadium III des Hypopharynx
- Plattenepithelkarzinom des Hypopharynx im Stadium IV
- Plattenepithelkarzinom des Kehlkopfes im Stadium III
- Plattenepithelkarzinom des Kehlkopfes im Stadium IV
- Plattenepithelkarzinom im Stadium III der Nasennebenhöhlen und der Nasenhöhle
- Plattenepithelkarzinom im Stadium IV der Nasennebenhöhlen und der Nasenhöhle
- Stadium II Plattenepithelkarzinom des Hypopharynx
- Zungenkrebs
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 06-130
- MSKCC-06130
- PFIZER-MSKCC-06130
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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