Trial Outcomes & Findings for Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer (NCT NCT00591149)
NCT ID: NCT00591149
Last Updated: 2017-06-14
Results Overview
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and 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 (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
12 Weeks, 1 Year
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Oxaliplatin and Docetaxel
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Oxaliplatin and Docetaxel
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Oxalipatin and Docetaxel
n=16 Participants
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Weeks, 1 YearResponse Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and 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 (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Oxaliplatin and Docetaxel
n=16 Participants
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
|
|---|---|
|
Efficacy Measured by Response Rate in Participants
Complete Response
|
0 participants
|
|
Efficacy Measured by Response Rate in Participants
Partial Response
|
2 participants
|
|
Efficacy Measured by Response Rate in Participants
Stable Disease
|
6 participants
|
|
Efficacy Measured by Response Rate in Participants
Progressive Disease
|
3 participants
|
|
Efficacy Measured by Response Rate in Participants
Not Evaluable
|
5 participants
|
Adverse Events
Oxaliplatin and Docetaxel
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxaliplatin and Docetaxel
n=16 participants at risk
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection, lung (Pneumonia)
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Multi-organ failure
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Sepsis
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Oxaliplatin and Docetaxel
n=16 participants at risk
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles
Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
|
|---|---|
|
Investigations
Alanine aminotrasferase increased
|
25.0%
4/16 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
4/16 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
5/16 • Number of events 8
|
|
Investigations
Aspartate aminotrasferase increased
|
25.0%
4/16 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
2/16 • Number of events 4
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • Number of events 3
|
|
Infections and infestations
Colitis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 3
|
|
Investigations
Creatinine increased
|
18.8%
3/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
4/16 • Number of events 5
|
|
Ear and labyrinth disorders
Abnormal ear, nose and throat examination
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Edema: limbs
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Edema: Head and Neck
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Elevated Alkaline Phosphatase
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Elevated blood urea nitrogen
|
12.5%
2/16 • Number of events 3
|
|
Infections and infestations
Esophagitis
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue
|
62.5%
10/16 • Number of events 20
|
|
Infections and infestations
Fever
|
18.8%
3/16 • Number of events 5
|
|
Infections and infestations
Gastritis
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
12.5%
2/16 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemolysis
|
31.2%
5/16 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Hiccup
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Hyperbilirubinemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.8%
3/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.2%
5/16 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.2%
5/16 • Number of events 11
|
|
Infections and infestations
Infection, mucosa
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
56.2%
9/16 • Number of events 21
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness: lower limb
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Tissue necrosis: neck
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
37.5%
6/16 • Number of events 12
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
37.5%
6/16 • Number of events 13
|
|
Blood and lymphatic system disorders
Decreased platelets
|
31.2%
5/16 • Number of events 7
|
|
Infections and infestations
Lung infection: Pneumonia
|
12.5%
2/16 • Number of events 2
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
4/16 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
dysgeusia
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Trigeminal nerve disorder
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
6.2%
1/16 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place