Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01794845
Recruitment Status : Terminated (Early termination due to lack of efficacy (overall response))
First Posted : February 20, 2013
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Matthew Abramowitz, University of Miami

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Squamous Cell Carcinoma
Head and Neck Cancer
Recurrent Disease
Interventions Drug: Erbitux
Drug: Taxotere
Radiation: Low Dose Fractionated Radiation Therapy
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erbitux, Taxotere, LD Fractionated RT
Hide Arm/Group Description

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

  • Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
  • Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
  • Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Erbitux, Taxotere, LD Fractionated RT
Hide Arm/Group Description

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

  • Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
  • Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
  • Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  50.0%
>=65 years
2
  50.0%
[1]
Measure Analysis Population Description: Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
[1]
Measure Analysis Population Description: Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
Site of Head and Neck Carcinoma   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Larynx
2
  50.0%
Floor of Mouth
1
  25.0%
Tonsil
1
  25.0%
[1]
Measure Analysis Population Description: Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Surgery   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
1
  25.0%
[1]
Measure Description: Number of study participants receiving surgery as treatment for primary tumor.
[2]
Measure Analysis Population Description: Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Chemotherapy   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
3
  75.0%
[1]
Measure Description: Number of study participants receiving chemotherapy as treatment for primary tumor.
[2]
Measure Analysis Population Description: Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
1.Primary Outcome
Title Overall Response Rate (ORR) of Participants
Hide Description ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
Time Frame Up to 6 months from End of Treatment, about 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Arm/Group Title Erbitux, Taxotere, LD Fractionated RT
Hide Arm/Group Description:

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

  • Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
  • Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
  • Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percentage of participants
Overall Response (CR+PR), 1 month 50
Overall Response (CR+PR), 6 months 0
Complete Response (CR), 1 month 0
Complete Response (CR), 6 months 0
Partial Response (PR), 1 month 50
Partial Response (PR), 6 months 0
Stable Disease (SD), 1 month 25
Stable Disease (SD), 6 months 0
Progressive Disease (PD), 1 month 25
Progressive Disease (PD), 6 months 100
2.Secondary Outcome
Title Number of Study Participants Experiencing Treatment-Related Toxicity
Hide Description

Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:

  • Acute toxicity is defined as toxicity occurring within 90 days of start of therapy.
  • Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Arm/Group Title Erbitux, Taxotere, LD Fractionated RT
Hide Arm/Group Description:

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

  • Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
  • Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
  • Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Acute Toxicities
4
 100.0%
Late Toxicities
0
   0.0%
3.Secondary Outcome
Title Estimated Progression-Free Survival (PFS)
Hide Description Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Progression-free survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.
Arm/Group Title Erbitux, Taxotere, LD Fractionated RT
Hide Arm/Group Description:

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

  • Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
  • Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
  • Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Estimated Overall Survival (OS)
Hide Description Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Overall survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.
Arm/Group Title Erbitux, Taxotere, LD Fractionated RT
Hide Arm/Group Description:

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

  • Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
  • Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
  • Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
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 Erbitux, Taxotere, LD Fractionated RT
Hide Arm/Group Description

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

  • Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
  • Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
  • Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
All-Cause Mortality
Erbitux, Taxotere, LD Fractionated RT
Affected / at Risk (%)
Total   1/4 (25.00%)    
Hide Serious Adverse Events
Erbitux, Taxotere, LD Fractionated RT
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Vascular disorders   
Hematoma  1  1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erbitux, Taxotere, LD Fractionated RT
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/4 (25.00%)  2
Ear and labyrinth disorders   
Ear pain  1  1/4 (25.00%)  1
Gastrointestinal disorders   
Constipation  1  1/4 (25.00%)  1
Dehydration  1  1/4 (25.00%)  1
Dry mouth/salivary gland (xerostomia)  1  2/4 (50.00%)  2
Dysphagia  1  2/4 (50.00%)  2
General disorders   
Insomnia  1  1/4 (25.00%)  1
Pain  1  1/4 (25.00%)  2
Infections and infestations   
Paronychia  1  1/4 (25.00%)  1
Injury, poisoning and procedural complications   
Dermatitis radiation  1  1/4 (25.00%)  1
Investigations   
Lymphocyte count decreased  1  1/4 (25.00%)  1
Metabolism and nutrition disorders   
Hyperkalemia  1  1/4 (25.00%)  4
Hypermagnesemia  1  1/4 (25.00%)  1
Hypoalbuminemia  1  1/4 (25.00%)  1
Nervous system disorders   
Dysgeusia  1  1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/4 (25.00%)  2
Pruritus  1  1/4 (25.00%)  1
Rash acneiform  1  3/4 (75.00%)  7
Skin induration  1  1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Data analyzed for 4 out of 5 study participants due to 1 study participant withdrawing prior to receiving study therapy.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew C. Abramowitz MD
Organization: University of Miami
Phone: 305-243-4319
EMail: MAbramowitz@med.miami.edu
Layout table for additonal information
Responsible Party: Matthew Abramowitz, University of Miami
ClinicalTrials.gov Identifier: NCT01794845    
Other Study ID Numbers: 20090467
First Submitted: February 14, 2013
First Posted: February 20, 2013
Results First Submitted: February 8, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017