Trial Outcomes & Findings for Bevacizumab/Ph 2 for Locally Advanced Head and Neck Cancer (NCT NCT01588431)

Last Updated: 2024-02-14

Results Overview

Evaluate the rate of complete responses with induction therapy - Change in baseline regarding treatment/tumor response after 3 cycles of chemotherapy (3months); After 8 weeks of chemo + radiation; 1 year up to 10 years. This outcome will be measured with regards to number of participants via RECIST criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

1year up to 10 years

Results posted on

2024-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	(TPE-A) Followed by Concurrent RT(XPE-A), Surgery Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery: Induction therapy consists of 3 cycles of bevacizumab 15mg/kg on day 1, cetuximab weekly days 1,8,15 (loading dose of cetuximab 400mg/m2 on cycle 1, day 1, then 250 mg/m2 on all subsequent administrations), cisplatin 75mg/m2 on day 1, docetaxel 75mg/m2 on day 1, repeated every 21 days. After 3 cycles of induction therapy, patients will receive standard radiation 70-74 Gy/ 200 cGy/ daily, 5 days/ week with concurrent weekly cisplatin 30mg/m2, cetuximab 250mg/m2 and bevacizumab 15mg/kg every 3 weeks x 3. There is optional surgery for non-responders in the primary (stable disease) after TPE-A.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab/Ph 2 for Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(TPE-A) Followed by Concurrent RT(XPE-A), Surgery n=3 Participants Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery: Induction therapy consists of 3 cycles of bevacizumab 15mg/kg on day 1, cetuximab weekly days 1,8,15 (loading dose of cetuximab 400mg/m2 on cycle 1, day 1, then 250 mg/m2 on all subsequent administrations), cisplatin 75mg/m2 on day 1, docetaxel 75mg/m2 on day 1, repeated every 21 days. After 3 cycles of induction therapy, patients will receive standard radiation 70-74 Gy/ 200 cGy/ daily, 5 days/ week with concurrent weekly cisplatin 30mg/m2, cetuximab 250mg/m2 and bevacizumab 15mg/kg every 3 weeks x 3. There is optional surgery for non-responders in the primary (stable disease) after TPE-A.
Age, Continuous	55.6 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 1year up to 10 years

Outcome measures

Outcome measures
Measure	(TPE-A) Followed by Concurrent RT(XPE-A), Surgery n=3 Participants Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery
Number of Participants With Response	0 Participants

SECONDARY outcome

Timeframe: 8 weeks up to 10 years

Population: No subjects completed the study, only one subject progressed to long term treatment, but did not survive to 10 years. Biomarkers on tissues were not performed since there were not enough evaluable samples.

Investigate a panel of Epidermal Growth Factor Receptor (EGFR) and angiogenesis biomarkers in pre- and post- treatment tumor biopsies and evaluate the associated treatment toxicities and the quality of life. After 8 weeks of chemo + radiation; 1 year up to 10 years.

Outcome measures

Outcome data not reported

Adverse Events

(TPE-A) Followed by Concurrent RT(XPE-A), Surgery

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	(TPE-A) Followed by Concurrent RT(XPE-A), Surgery n=3 participants at risk Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery: Induction therapy consists of 3 cycles of bevacizumab 15mg/kg on day 1, cetuximab weekly days 1,8,15 (loading dose of cetuximab 400mg/m2 on cycle 1, day 1, then 250 mg/m2 on all subsequent administrations), cisplatin 75mg/m2 on day 1, docetaxel 75mg/m2 on day 1, repeated every 21 days. After 3 cycles of induction therapy, patients will receive standard radiation 70-74 Gy/ 200 cGy/ daily, 5 days/ week with concurrent weekly cisplatin 30mg/m2, cetuximab 250mg/m2 and bevacizumab 15mg/kg every 3 weeks x 3. There is optional surgery for non-responders in the primary (stable disease) after TPE-A.
Blood and lymphatic system disorders Decreased White Blood Cell count	66.7% 2/3 • Number of events 2 • Baseline to 10 years
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 1 • Baseline to 10 years
Gastrointestinal disorders Appendicitis	33.3% 1/3 • Number of events 1 • Baseline to 10 years

Other adverse events

Other adverse events
Measure	(TPE-A) Followed by Concurrent RT(XPE-A), Surgery n=3 participants at risk Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery: Induction therapy consists of 3 cycles of bevacizumab 15mg/kg on day 1, cetuximab weekly days 1,8,15 (loading dose of cetuximab 400mg/m2 on cycle 1, day 1, then 250 mg/m2 on all subsequent administrations), cisplatin 75mg/m2 on day 1, docetaxel 75mg/m2 on day 1, repeated every 21 days. After 3 cycles of induction therapy, patients will receive standard radiation 70-74 Gy/ 200 cGy/ daily, 5 days/ week with concurrent weekly cisplatin 30mg/m2, cetuximab 250mg/m2 and bevacizumab 15mg/kg every 3 weeks x 3. There is optional surgery for non-responders in the primary (stable disease) after TPE-A.
Skin and subcutaneous tissue disorders Skin Rash	66.7% 2/3 • Number of events 2 • Baseline to 10 years
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • Number of events 1 • Baseline to 10 years
Blood and lymphatic system disorders Neutrofever	100.0% 3/3 • Number of events 3 • Baseline to 10 years
Blood and lymphatic system disorders Decreased platelet count	33.3% 1/3 • Number of events 1 • Baseline to 10 years
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • Baseline to 10 years
General disorders Weight loss	33.3% 1/3 • Number of events 1 • Baseline to 10 years
Gastrointestinal disorders Anorexia	66.7% 2/3 • Number of events 2 • Baseline to 10 years
General disorders Pain	33.3% 1/3 • Number of events 1 • Baseline to 10 years
Metabolism and nutrition disorders Transaminase imbalance	33.3% 1/3 • Number of events 1 • Baseline to 10 years
Endocrine disorders Low HbA1c	100.0% 3/3 • Number of events 3 • Baseline to 10 years

Additional Information

Anand Karnad, MD

UT Health San Antonio

Phone: 210-450-1267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place