Trial Outcomes & Findings for Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer (NCT NCT00423930)

Last Updated: 2017-08-18

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Percentage of Participants Experiencing Progression-free Survival at 2 Years

Results posted on

2017-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	IMRT + Cisplatin + Bevacizumab This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab. bevacizumab cisplatin conventional surgery intensity-modulated radiation therapy
Overall Study STARTED	44
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	IMRT + Cisplatin + Bevacizumab This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab. bevacizumab cisplatin conventional surgery intensity-modulated radiation therapy
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT + Cisplatin + Bevacizumab n=44 Participants This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab. bevacizumab cisplatin conventional surgery intensity-modulated radiation therapy
Age, Continuous	54 years n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	36 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	44 participants n=93 Participants

PRIMARY outcome

Timeframe: Percentage of Participants Experiencing Progression-free Survival at 2 Years

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin + Bevacizumab n=42 Participants This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab. bevacizumab cisplatin conventional surgery intensity-modulated radiation therapy
Progression-free Survival at 2 Years	75.9 percentage of participants Interval 63.9 to 90.1

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	IMRT + Cisplatin + Bevacizumab n=42 Participants This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab. bevacizumab cisplatin conventional surgery intensity-modulated radiation therapy
Overall Survival Rate: Percentage of Participants Who Survived	88 percentage of participants Interval 78.6 to 98.4

Adverse Events

IMRT + Cisplatin + Bevacizumab

Serious events: 28 serious events

Other events: 42 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	IMRT + Cisplatin + Bevacizumab n=42 participants at risk This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab. bevacizumab cisplatin conventional surgery intensity-modulated radiation therapy
Investigations ALT	4.8% 2/42
Investigations AST	4.8% 2/42
Investigations Alkaline Phosphatase	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Aspiration	2.4% 1/42
Investigations Hyperbilirubinemia	2.4% 1/42
Nervous system disorders CNS cerebrovascular ischemia	2.4% 1/42
Psychiatric disorders Confusion	7.1% 3/42
Gastrointestinal disorders Constipation	9.5% 4/42
Respiratory, thoracic and mediastinal disorders Cough	2.4% 1/42
Investigations Creatinine	7.1% 3/42
General disorders Death NOS	2.4% 1/42
Metabolism and nutrition disorders Dehydration	9.5% 4/42
Gastrointestinal disorders Diarrhea	2.4% 1/42
Gastrointestinal disorders Dysphagia	2.4% 1/42
Gastrointestinal disorders Esophagitus	2.4% 1/42
General disorders Fatigue	11.9% 5/42
Blood and lymphatic system disorders Febrile Neutropenia	16.7% 7/42
General disorders Fever (in the absence of neutropenia)	7.1% 3/42
Metabolism and nutrition disorders Hyperglycemia	2.4% 1/42
Blood and lymphatic system disorders Hemoglobin/Anemia	16.7% 7/42
Respiratory, thoracic and mediastinal disorders Hemorrhage, Nose/Epistaxis	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Hemmorhage, Pharynx	2.4% 1/42
Gastrointestinal disorders Hemorrhage, Rectum	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Hemorrhage, Respiratory tract NOS	2.4% 1/42
Gastrointestinal disorders Hemorrhage, Upper GI NOS	2.4% 1/42
General disorders Hemorrhage/Bleeding, other	7.1% 3/42
Vascular disorders Hypertension	2.4% 1/42
Vascular disorders Hypotension	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 2/42
Investigations INR	2.4% 1/42
Infections and infestations Pneumonia	4.8% 2/42
Investigations Leukoctyes (total WBC)	14.3% 6/42
Investigations Lymphopenia	21.4% 9/42
Gastrointestinal disorders Mucositis - Oral Cavity	9.5% 4/42
Gastrointestinal disorders Nausea	28.6% 12/42
Investigations Neutrophils/Granulocytes	19.0% 8/42
Musculoskeletal and connective tissue disorders Pain - Extremity/Limb	2.4% 1/42
Musculoskeletal and connective tissue disorders Neck pain	2.4% 1/42
General disorders Pain - other	4.8% 2/42
Respiratory, thoracic and mediastinal disorders Pain - throat/pharynx/larynx	4.8% 2/42
Vascular disorders Peripheral arterial ischemia	2.4% 1/42
Metabolism and nutrition disorders Phosphate, low	4.8% 2/42
Respiratory, thoracic and mediastinal disorders Pleural effusion (non malignant)	2.4% 1/42
Metabolism and nutrition disorders Hyperkalemia	2.4% 1/42
Metabolism and nutrition disorders Hypokalemia	2.4% 1/42
Cardiac disorders Prolonged QTc interval	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - other	2.4% 1/42
Metabolism and nutrition disorders Hyponatremia	7.1% 3/42
Nervous system disorders Syncope	4.8% 2/42
Vascular disorders Thrombosis/thrombus/embolism	9.5% 4/42
Renal and urinary disorders Urinary retention	2.4% 1/42
Cardiac disorders Valvular heart disease	2.4% 1/42
Gastrointestinal disorders Vomiting	31.0% 13/42
Investigations Weight loss	4.8% 2/42

Other adverse events

Other adverse events
Measure	IMRT + Cisplatin + Bevacizumab n=42 participants at risk This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab. bevacizumab cisplatin conventional surgery intensity-modulated radiation therapy
General disorders Fatigue	100.0% 42/42
Metabolism and nutrition disorders Hyperglycemia	100.0% 42/42
Blood and lymphatic system disorders Anemia	100.0% 42/42
Investigations Leukocytes (total WBC)	100.0% 42/42
Investigations Lymphopenia	100.0% 42/42
Gastrointestinal disorders Mucositis - Oral Cavity	100.0% 42/42
Respiratory, thoracic and mediastinal disorders Pain - throat/pharynx/larynx	100.0% 42/42
Gastrointestinal disorders Constipation	95.2% 40/42
Gastrointestinal disorders Nausea	95.2% 40/42
Investigations Weight loss	90.5% 38/42
Metabolism and nutrition disorders Hyponatremia	88.1% 37/42
Metabolism and nutrition disorders Hypoalbuminemia	85.7% 36/42
Investigations Platelets	78.6% 33/42
Gastrointestinal disorders Vomiting	76.2% 32/42
Investigations ALT	73.8% 31/42
Investigations Neutrophils/granulocytes	66.7% 28/42
Ear and labyrinth disorders Tinnitus	66.7% 28/42
Gastrointestinal disorders Diarrhea	59.5% 25/42
Respiratory, thoracic and mediastinal disorders Cough	57.1% 24/42
Investigations Creatinine	57.1% 24/42
Investigations AST	52.4% 22/42
Metabolism and nutrition disorders Hyperkalemia	42.9% 18/42
Injury, poisoning and procedural complications Dermatitis Radiation	40.5% 17/42
Investigations Alkaline phosphatase	38.1% 16/42
Vascular disorders Hypertension	35.7% 15/42
Metabolism and nutrition disorders Hypomagnesemia	35.7% 15/42
Metabolism and nutrition disorders Hypokalemia	35.7% 15/42
Infections and infestations Mucosal infection	33.3% 14/42
Gastrointestinal disorders Oral Pain	33.3% 14/42
Metabolism and nutrition disorders Hypernatremia	33.3% 14/42
Metabolism and nutrition disorders Dehydration	28.6% 12/42
Nervous system disorders Peripheral sensory neuropathy	28.6% 12/42
General disorders Fever	26.2% 11/42
Gastrointestinal disorders Dyspepsia	26.2% 11/42
Metabolism and nutrition disorders Hypoglycemia	23.8% 10/42
Investigations Blood bilirubin increased	21.4% 9/42
Investigations INR	21.4% 9/42
Nervous system disorders Dizziness	19.0% 8/42
Nervous system disorders Headache	19.0% 8/42
Musculoskeletal and connective tissue disorders Trismus	19.0% 8/42
Gastrointestinal disorders Dry mouth	19.0% 8/42
Blood and lymphatic system disorders Febrile neutropenia	16.7% 7/42
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Hemorrhage	16.7% 7/42
Nervous system disorders Dysgeusia	16.7% 7/42
Respiratory, thoracic and mediastinal disorders Hiccups	14.3% 6/42
Renal and urinary disorders Urinary frequency/urgency	14.3% 6/42
General disorders Edema: limb	11.9% 5/42
Psychiatric disorders Anxiety	11.9% 5/42
Metabolism and nutrition disorders Hypophosphatemia	11.9% 5/42
Metabolism and nutrition disorders Anorexia	9.5% 4/42
Metabolism and nutrition disorders Bicarbonate, serum-low	9.5% 4/42
Investigations Cholesterol, high	9.5% 4/42
Respiratory, thoracic and mediastinal disorders Epistaxis	9.5% 4/42
Ear and labyrinth disorders Pain - middle ear	9.5% 4/42
Skin and subcutaneous tissue disorders Rash acneiform	9.5% 4/42
Psychiatric disorders Confusion	7.1% 3/42
Renal and urinary disorders Urinary incontinence	7.1% 3/42
Investigations PTT	7.1% 3/42
Musculoskeletal and connective tissue disorders Back pain	7.1% 3/42
Musculoskeletal and connective tissue disorders Neck pain	7.1% 3/42
Cardiac disorders Sinus bradycardia	7.1% 3/42
Vascular disorders Thrombosis/thrombus/embolism	7.1% 3/42
Metabolism and nutrition disorders Hypertriglyceridemia	7.1% 3/42

Additional Information

David Pfister, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place