- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01790516
Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
A Pilot Prospective Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery.
The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy with curative intent will be enrolled. Patients will be genotyped for germline variations at four SNP loci in three genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm A). Patients with 2 or fewer variants will receive cetuximab (Arm B).
The hypothesis of the study is that prospectively testing patients for variations in DNA repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head and neck squamous cell cancer is feasible.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
District of Columbia
-
Washington, District of Columbia, Verenigde Staten, 20007
- Georgetown Lombardi Comprhensive Cancer Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Biopsy proven squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, or larynx, but not including primary tumors of the nasopharynx, sinuses, or salivary glands.
- Locally advanced, Stage III to IVB disease, and a candidate for primary therapy using chemotherapy and radiation therapy with curative intent.
- Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is the primary modality of treatment
- No previous chemotherapy, radiation, or surgery for their diagnosis of head and neck cancer
- Eastern Cooperative Oncology Group performance status </= 1
- Women of child-bearing potential must have a negative pregnancy test within 30 hours before initiation of study drug dosing. Female subjects of reproductive potential must agree to avoid pregnancy throughout the study and for up to 3 months following discontinuation of study drug. Male subjects must agree to avoid conceiving a child throughout the study and for up to 3 months following discontinuation of study drug;
- Hemoglobin >/= 8.0 gm/dL
- Absolute neutrophil count >/= 1500
- Platelet count >/= 100,000
- Glomerular Filtration Rate > 50 mL/min calculated by the Cockcroft-Gault equation
- Total bilirubin </= 2.0 times the upper limit of normal unless the patient has Gilbert's syndrome
- Aspartate aminotransferase and Alanine Aminotransferase </= 2.5 times the upper limit of normal
- No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for >/= 3 years prior to screening for this protocol.
- Age of 18 or older
- Ability and willingness to give informed consent
- Subjects must in the opinion of the Investigator be capable of complying with this protocol.
Exclusion Criteria:
- Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- Major surgery within 3 weeks prior to study entry
- Known hypersensitivity to cisplatin or cetuximab
- Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study, including: unstable angina, serious uncontrolled cardiac arrhythmia, active acute or uncontrolled infectious disorder, or myocardial infarction </= 6 months prior to study entry.
- Female patients who are pregnant or breast feeding, or adults who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment.
- Patients unwilling to comply with the protocol, or provide informed consent
- Psychiatric illness that would limit compliance with study requirements
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Cisplatin
|
Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
Andere namen:
daily radiation for 7 weeks
|
Experimenteel: Cetuximab
cetuximab
|
daily radiation for 7 weeks
Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician
Tijdsspanne: 20 months
|
Feasibility is defined as follows: - Patients' genetic test results are returned to the treating physician within 3 days |
20 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: John F Deeken, MD, Georgetown University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2010-439
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Cisplatin
-
Third Military Medical UniversityOnbekendBehandeling | Diagnose stellen van ziekten | Longadenocarcinoom, stadium I | Circulerende tumorcellenChina
-
Centre Oscar LambretNational Cancer Institute, FranceBeëindigdPlaveiselcelcarcinoom van de slokdarmFrankrijk
-
Hunan Province Tumor HospitalWervingLongadenocarcinoom | ALK-genmutatie | ImmunotherapieChina