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Trial record 10 of 42 for:    "Buffalo" AND "Singh"

Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00891904
Recruitment Status : Terminated (Low accrual)
First Posted : May 1, 2009
Results First Posted : March 12, 2014
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Interventions Biological: cetuximab
Radiation: stereotactic body radiation therapy
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Biological/Vaccine: Cetuximab
Hide Arm/Group Description

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Death             1
Adverse Event             1
Arm/Group Title Biological/Vaccine: Cetuximab
Hide Arm/Group Description

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
67  (2.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
1.Primary Outcome
Title Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Hide Description [Not Specified]
Time Frame Daily while on Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Trial terminated early. Too few patients to analyze.
Arm/Group Title Biological/Vaccine: Cetuximab
Hide Arm/Group Description:

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Trial terminated early. Too few patients to analyze.
Arm/Group Title Biological/Vaccine: Cetuximab
Hide Arm/Group Description:

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Local and Distant Control
Hide Description [Not Specified]
Time Frame very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
Hide Outcome Measure Data
Hide Analysis Population Description
Trial terminated early. Too few patients to analyze.
Arm/Group Title Biological/Vaccine: Cetuximab
Hide Arm/Group Description:

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
Trial terminated early. Too few patients to analyze.
Arm/Group Title Biological/Vaccine: Cetuximab
Hide Arm/Group Description:

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Biological/Vaccine: Cetuximab
Hide Arm/Group Description

All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.

250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).

All-Cause Mortality
Biological/Vaccine: Cetuximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Biological/Vaccine: Cetuximab
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Infections and infestations   
Pneumonia   1/2 (50.00%)  2
Postoperative wound infection   1/2 (50.00%)  4
Investigations   
Alanine aminotransferase increased   1/2 (50.00%)  4
Aspartate aminotransferase increased   1/2 (50.00%)  4
Metabolism and nutrition disorders   
Dehydration   1/2 (50.00%)  4
Hypoalbuminaemia   1/2 (50.00%)  4
Hypocalcaemia   1/2 (50.00%)  4
Hypokalaemia   1/2 (50.00%)  4
Hyponatraemia   1/2 (50.00%)  4
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Biological/Vaccine: Cetuximab
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Blood and lymphatic system disorders   
White blood cell disorder   1/2 (50.00%)  4
Gastrointestinal disorders   
Nausea   1/2 (50.00%)  4
Investigations   
Alanine aminotransferase increased   1/2 (50.00%)  4
Aspartate aminotransferase increased   1/2 (50.00%)  4
Haemoglobin decreased   1/2 (50.00%)  4
Neutrophil count decreased   1/2 (50.00%)  8
Platelet count decreased   1/2 (50.00%)  4
Metabolism and nutrition disorders   
Hyperkalaemia   1/2 (50.00%)  4
Hyponatraemia   1/2 (50.00%)  4
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain   1/2 (50.00%)  4
Skin and subcutaneous tissue disorders   
Drug eruption   1/2 (50.00%)  4
Indicates events were collected by systematic assessment
Trial terminated early. Too few patients to analyze.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00891904     History of Changes
Other Study ID Numbers: CDR0000640992
RPCI-I-143108
First Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: January 29, 2014
Results First Posted: March 12, 2014
Last Update Posted: April 14, 2016