Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442455
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2007-03-01
Brief Title:
ErlotinibRadiation and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Grupo de Investigación Clínica en Oncología Radioterapia
Organization:
Grupo de Investigación Clínica en Oncología Radioterapia
Study Overview
Official Title:
Phase III Trial of Erlotinib Radiation Therapy and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determinate the free-progression interval in patients with surgically resected locally advanced squamous cell carcinoma of head and neck treated with the maximum tolerated dose of the combination of erlotinib radiation therapy and cisplatin previously established in a safety trial
Detailed Description:
Phase I
3 cohorts of 3-6 patients patients will received
Erlotinib 100-150 mgday po for 7 weeks
Cisplatin 30-40 mgm2 iv weekly for 7 weeks
Radiation therapy 63 Gy five days a week for 7 weeks Cohort 1 3 patients will be included in cohort 1
If no DLT has been recorded in the first three patients during the 7-weeks treatment the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated
If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment then the first cohort will be expanded to 6 patients
If no further DLT has been recorded in patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in one out of the patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 1 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
If DLT has been recorded in 2 patients of the first three patients during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
Cohort 2
If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 1 3 patients will be included in cohort 2
If no DLT has been recorded in the first three patients during the 7-weeks treatment the dose level of cisplatin will be escalated to 40 mgm2 and enrollment of cohort 3 will be initiated
If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment then the second cohort will be expanded to 6 patients
If no further DLT has been recorded in patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle the dose level of cisplatin will be escalated to 40 mgm2 and enrollment of cohort 3 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in one out of the patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle the dose level of cisplatin will be escalated to 40 mgm2 and enrollment of cohort 3 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 2 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
If DLT has been recorded in 2 patients of the first three patients of cohort 2 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
Cohort 3
If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 2 3 patients will be included in cohort 2
If no DLT has been recorded in the first three patients during the 7-weeks treatment then the Maximum Tolerated Dose has not been reached
If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment then the third cohort will be expanded to 6 patients
If no further DLT has been recorded in patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle then the Maximum Tolerated Dose has not been reached
If DLT has been recorded in one out of the patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle then the Maximum Tolerated Dose has not been reached
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 3 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
If DLT has been recorded in 2 patients of the first three patients of cohort 3 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
Inclusion of the third patient of each cohort will not be allowed until the safety data from the two previous patients have been analyzed
Inclusion of the third patient of each cohort will not be allowed until the safety data from the two previous patients have been analyzed
DLT is defined as
Any clinically intolerable hematological or non-hematological grade 3-4 toxicity
Grade 3-4 diarrhoea
Grade 3-4 or clinically intolerable grade 2 skin rash
Grade 4 mucositis implying a temporary interruption of radiation therapy for longer than 2 consecutive weeks
Grade 4 mucositis occurring within the first 3 weeks of treatment
Grade 3-4 mucositis accompanied by one of the following toxicities
Worsening of performance status defined as ECOG 2 or a decrease of 40 in the Karnofsky performance status scale
Grade 3 Weight loss corresponding to a weight loss of 20 with respect to baseline weight
Underlying pain not including swallowing VAS 7
Parenteral nutrition
Any clinically significant toxicity involving treatment interruption for a period longer than two weeks
Maximum Tolerated Dose is defined as the dose level at which 2 patients of the first three patients of one cohort or 3 of the 6 patients of one cohort exhibit one DLT during the 7-weeks treatment
Phase II
75 patients will be treated at dose step below MTD to determinate
Progression Free Survival defined as the period of time from the surgery until disease progression or death
Overall survival
Locoregional progression-free survival
A tumor assessment will be performed 30 days after the end of treatment and every 3 months until disease progression afterwards
3 cohorts of 3-6 patients patients will received
Erlotinib 100-150 mgday po for 7 weeks
Cisplatin 30-40 mgm2 iv weekly for 7 weeks
Radiation therapy 63 Gy five days a week for 7 weeks Cohort 1 3 patients will be included in cohort 1
If no DLT has been recorded in the first three patients during the 7-weeks treatment the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated
If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment then the first cohort will be expanded to 6 patients
If no further DLT has been recorded in patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in one out of the patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 1 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
If DLT has been recorded in 2 patients of the first three patients during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
Cohort 2
If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 1 3 patients will be included in cohort 2
If no DLT has been recorded in the first three patients during the 7-weeks treatment the dose level of cisplatin will be escalated to 40 mgm2 and enrollment of cohort 3 will be initiated
If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment then the second cohort will be expanded to 6 patients
If no further DLT has been recorded in patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle the dose level of cisplatin will be escalated to 40 mgm2 and enrollment of cohort 3 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in one out of the patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle the dose level of cisplatin will be escalated to 40 mgm2 and enrollment of cohort 3 will be initiated after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 2 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
If DLT has been recorded in 2 patients of the first three patients of cohort 2 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
Cohort 3
If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 2 3 patients will be included in cohort 2
If no DLT has been recorded in the first three patients during the 7-weeks treatment then the Maximum Tolerated Dose has not been reached
If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment then the third cohort will be expanded to 6 patients
If no further DLT has been recorded in patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle then the Maximum Tolerated Dose has not been reached
If DLT has been recorded in one out of the patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle then the Maximum Tolerated Dose has not been reached
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 3 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
If DLT has been recorded in 2 patients of the first three patients of cohort 3 during the during the 7-weeks treatment then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose MTD
Inclusion of the third patient of each cohort will not be allowed until the safety data from the two previous patients have been analyzed
Inclusion of the third patient of each cohort will not be allowed until the safety data from the two previous patients have been analyzed
DLT is defined as
Any clinically intolerable hematological or non-hematological grade 3-4 toxicity
Grade 3-4 diarrhoea
Grade 3-4 or clinically intolerable grade 2 skin rash
Grade 4 mucositis implying a temporary interruption of radiation therapy for longer than 2 consecutive weeks
Grade 4 mucositis occurring within the first 3 weeks of treatment
Grade 3-4 mucositis accompanied by one of the following toxicities
Worsening of performance status defined as ECOG 2 or a decrease of 40 in the Karnofsky performance status scale
Grade 3 Weight loss corresponding to a weight loss of 20 with respect to baseline weight
Underlying pain not including swallowing VAS 7
Parenteral nutrition
Any clinically significant toxicity involving treatment interruption for a period longer than two weeks
Maximum Tolerated Dose is defined as the dose level at which 2 patients of the first three patients of one cohort or 3 of the 6 patients of one cohort exhibit one DLT during the 7-weeks treatment
Phase II
75 patients will be treated at dose step below MTD to determinate
Progression Free Survival defined as the period of time from the surgery until disease progression or death
Overall survival
Locoregional progression-free survival
A tumor assessment will be performed 30 days after the end of treatment and every 3 months until disease progression afterwards
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None