Trial Outcomes & Findings for Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT01289522)

Last Updated: 2017-05-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

12 weeks (after completion of the 4th cycle of chemotherapy)

Results posted on

2017-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cetuximab cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only. * 250 mg/m² over 60 minutes weekly on subsequent administrations * 500mg/m2 every 2 weeks during the maintenance therapy. Drug: -Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles * Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support mandatory after each cycle of chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the 4th cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks.
Overall Study STARTED	54
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab n=54 Participants 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 cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only. * 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. * 500mg/m2 IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy. Biopsies: No intervention, only biopsy for translational project.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	57.8 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment Belgium	8 participants n=5 Participants
Region of Enrollment France	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks (after completion of the 4th cycle of chemotherapy)

Outcome measures

Outcome measures
Measure	Cetuximab n=54 Participants 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 cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only. * 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. * 500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy. Biopsies: No intervention, only biopsy for translational project.
Objective Tumor Response Rate	44 percentage of participants Interval 30.9 to 58.6

SECONDARY outcome

Timeframe: 24 weeks (average)

All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.

Outcome measures

Outcome measures
Measure	Cetuximab n=54 Participants 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 cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only. * 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. * 500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy. Biopsies: No intervention, only biopsy for translational project.
Grade 1 to 5 Toxicity	50 percentage of events

SECONDARY outcome

Timeframe: 12 weeks

Population: 2 patients not assessable for response at 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.

Outcome measures

Outcome measures
Measure	Cetuximab n=52 Participants 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 cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only. * 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. * 500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy. Biopsies: No intervention, only biopsy for translational project.
Best Overall Response	53.7 percentage of Best overall ORR Interval 39.6 to 67.4

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years

Outcome measures

Outcome data not reported

Adverse Events

Cetuximab

Serious events: 15 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab n=54 participants at risk 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 cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only. * 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. * 500mg/m2 IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy. Biopsies: No intervention, only biopsy for translational project.
Blood and lymphatic system disorders arterial rupture	3.7% 2/54 • Number of events 2
Blood and lymphatic system disorders Febrile neutropenia	5.6% 3/54 • Number of events 3
Metabolism and nutrition disorders Oral intake reduced	1.9% 1/54 • Number of events 1
Gastrointestinal disorders Acute alcoholic hepatitis	1.9% 1/54 • Number of events 1
Metabolism and nutrition disorders Anorexia	1.9% 1/54 • Number of events 1
Respiratory, thoracic and mediastinal disorders Bronchial infection	1.9% 1/54 • Number of events 1
Infections and infestations Central line infection	1.9% 1/54 • Number of events 1
Skin and subcutaneous tissue disorders Drug eruption	1.9% 1/54 • Number of events 1
Immune system disorders Drug hypersensitivity	1.9% 1/54 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	1.9% 1/54 • Number of events 1
Blood and lymphatic system disorders Febrile bone marrow aplasia	1.9% 1/54 • Number of events 1
Blood and lymphatic system disorders haemoptysis	1.9% 1/54 • Number of events 1
Blood and lymphatic system disorders Leukopenia	1.9% 1/54 • Number of events 1

Other adverse events

Other adverse events
Measure	Cetuximab n=54 participants at risk 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 cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only. * 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. * 500mg/m2 IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy. Biopsies: No intervention, only biopsy for translational project.
Blood and lymphatic system disorders anemia	3.7% 2/54 • Number of events 2
Blood and lymphatic system disorders Lymphopenia	3.7% 2/54 • Number of events 2
Investigations Hyponatremia	1.9% 1/54 • Number of events 1
Investigations hypokalemia	3.7% 2/54 • Number of events 2
Gastrointestinal disorders diarrhea	3.7% 2/54 • Number of events 2
Gastrointestinal disorders oral mucositis	5.6% 3/54 • Number of events 3
General disorders fever	1.9% 1/54 • Number of events 1
Respiratory, thoracic and mediastinal disorders pneumonitis	1.9% 1/54 • Number of events 1
Gastrointestinal disorders nausea	1.9% 1/54 • Number of events 1
Renal and urinary disorders renal failure	1.9% 1/54 • Number of events 1
Ear and labyrinth disorders hearing loss	1.9% 1/54 • Number of events 1
Skin and subcutaneous tissue disorders skin toxicities	13.0% 7/54 • Number of events 7
Blood and lymphatic system disorders neutropenia	20.4% 11/54 • Number of events 11

Additional Information

Pr. Joël GUIGAY

Centre Antoine Lacassagne

Phone: +33492031000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60