- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01289522
Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (TPEx)
Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- To determine the efficacy of TPEx combination in patients with head and neck cancer in term of objective response rate (RECIST, see statistical consideration) Secondary
- To assess toxicities of TPEx combination
- Determine the efficacy of TPEx combination in patients with head and neck cancer: Best Overall Response , progression-free survival and survival.
- Translational research objective:To better understand the mechanisms of chemoresistance and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. Tumor check-up will be performed every 6 weeks. This study will allow translational research with blood sample and biopsies at baseline before any treatment, during the treatment with TPEx combination (week 6).,After completion of study treatment, patients are followed every 2 months.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
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Bruxelles, Belgien
- Cliniques Universitaires
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Namur, Belgien
- Clinique Sainte Elisabeth
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Yvoir, Belgien
- Clinique universitaire de Mont Godinne UCL
-
-
-
-
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Bordeaux, Frankrike
- Hopital Saint Andre
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Clermont-Ferrand, Frankrike
- Centre Jean Perrin,
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Dijon, Frankrike
- Centre G-F Leclerc
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Draguignan, Frankrike
- Centre Hospitalier de la Dracénie
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Lorient, Frankrike
- Centre Hospitalier de Bretagne Sud
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Lyon, Frankrike
- Centre Leon Berard
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Marseille, Frankrike
- Hopital de la Timone
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Rouen, Frankrike
- Centre Henri Becquerel
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Suresnes, Frankrike
- Hôpital FOCH
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Tours, Frankrike
- CHU Bretonneau
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Villejuif, Frankrike
- Institut Gustave Roussy
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
- Measurable or evaluable disease
- Age > 18 years and <= 70 years
- WHO performance status 0 or 1
- Absolute neutrophil count > 1,500/mm3
- Platelets > 150,000/mm3
- Total Bilirubin <= institutional upper limit of normal
- Aspartate aminotransferase < 1.5 X institutional upper limit of normal
- Alanine aminotransferase < 1.5 X institutional upper limit of normal
- Alkaline phosphatase < 2.5 X institutional upper limit of normal
- creatinine clearance > 60 mL/min
- Signed informed consent
- Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment
Exclusion Criteria:
- Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed
- Previous treatment with total doses of cisplatin > 300 mg/ m2
- Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure
- Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry
- Nasopharyngeal carcinoma, or cancer of sinusal cavities
- Active infection including tuberculosis or HIV positive patient
- Other malignancy within last 5 years except for non-melanoma skin cancer
- No other investigational agent within 30 days prior to study entry
- No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications
- No prior anti EGFR therapy
- No known brain metastases
- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
- Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis
- No history of hypersensitivity reaction to drugs on study
- No unstable angina or myocardial infarction within the past 12 months
- No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease
- No serious uncontrolled cardiac arrhythmia
- No other prior or concomitant squamous cell carcinoma
- No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years
- Patient is pregnant or lactating
- Patients must not have any co-existing condition that would preclude full compliance with the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: cetuximab
Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks.
Treatment will be continued until disease progression or unacceptable toxicities according
|
Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.
No intervention, only biopsy for translational project.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective Tumor Response Rate
Tidsram: 12 weeks (after completion of the 4th cycle of chemotherapy)
|
The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
12 weeks (after completion of the 4th cycle of chemotherapy)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Total överlevnad
Tidsram: 1 år
|
1 år
|
|
Progressionsfri överlevnad
Tidsram: 1 år
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1 år
|
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Grade 1 to 5 Toxicity
Tidsram: 24 weeks (average)
|
All grade 1 to 5 toxicity are registered during treatment.
Patients have weekly clinical and biological examination.
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24 weeks (average)
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Best Overall Response
Tidsram: 12 weeks
|
Tumor response is evaluated every 6 weeks according to RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.
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12 weeks
|
Biomarkers
Tidsram: two years
|
two years
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Joel GUIGAY, GORTEC
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GORTEC 2008-03 TPEx
- 2008-004869-25 (EudraCT-nummer)
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