Trial Outcomes & Findings for Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer (NCT NCT00703976)

Last Updated: 2017-04-04

Results Overview

Two-year PFS is an estimated percentage of participants without disease progression (locoregional or distant) at two years after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as: at least a 20% (and at least 5 millimeters) increase in the sum of the diameters of target lesions, or the appearance of one or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

18 months to patient accrual and 2 years of follow-up after closing accrual.

Results posted on

2017-04-04

Participant Flow

Although 80 patients were enrolled, only 78 began the study because 2 were found to be ineligible prior to treatment.

Participant milestones

Participant milestones
Measure	Cetuximab, Pemetrexed and Radiation Therapy Cetuximab, Pemetrexed and Radiation therapy Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks	Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.
Overall Study STARTED	37	41
Overall Study COMPLETED	37	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab, Pemetrexed and Radiation Therapy n=37 Participants Cetuximab, Pemetrexed and Radiation therapy Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks	Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab n=41 Participants Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.	Total n=78 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months to patient accrual and 2 years of follow-up after closing accrual.

Outcome measures

Outcome measures
Measure	Cetuximab, Pemetrexed and Radiation Therapy n=37 Participants Cetuximab, Pemetrexed and Radiation therapy Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks	Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab n=41 Participants Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.	Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.
2-year Progression-free Survival (PFS)	79 percentage of participants Interval 69.0 to 92.0	75 percentage of participants Interval 64.0 to 88.0	—

SECONDARY outcome

Timeframe: 2 years of follow-up after closing accrual

Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.

Outcome measures

Outcome measures
Measure	Cetuximab, Pemetrexed and Radiation Therapy n=78 Participants Cetuximab, Pemetrexed and Radiation therapy Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks	Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab n=37 Participants Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.	Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab n=41 Participants Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy.
2-year Overall Survival (OS)	88 percentage of participants Interval 81.0 to 96.0	91 percentage of participants Interval 82.0 to 100.0	87 percentage of participants Interval 77.0 to 98.0

Adverse Events

All Participants (Overall Study)

Serious events: 31 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants (Overall Study) n=78 participants at risk
Blood and lymphatic system disorders Hemoglobin	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Leukocytes (total WBC)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Lymphopenia	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Neutrophils/granulocytes (ANC/AGC)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Hypotension	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Fatigue (asthenia, lethargy, malaise)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Weight loss	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Pruritus/itching	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: acne/acneiform	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation, Chemoradiation	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Constipation	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Dehydration	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Dysphagia (difficulty swallowing)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Gastrointestinal - Other	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Leak (including anastomotic), GI, Leak NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Mucositis/stomatitis (clinical exam), Oral cavity	7.7% 6/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic), Oral cavity	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Nausea	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Taste alteration (dysgeusia)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Ulcer, GI, Stomach	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Vomiting	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Hemorrhage, GI, Oral cavity	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, Pharynx	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin without documented infection)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection - Other	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), Skin (cellulitis)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Meninges (meningitis)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Confusion	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Dizziness	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Syncope (fainting)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Pain, Abdomen NOS	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Pain, Head/headache	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Pain, Oral cavity	7.7% 6/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pain, Throat/pharynx/larynx	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Cough	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Thrombosis/thrombus/embolism	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"

Other adverse events

Other adverse events
Measure	All Participants (Overall Study) n=78 participants at risk
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Ear and labyrinth disorders Auditory/Ear - Other	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Ear and labyrinth disorders Otitis, external ear (non-infectious)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Ear and labyrinth disorders Tinnitus	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Blood and lymphatic system disorders Blood/Bone Marrow - Other	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Haptoglobin	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Blood and lymphatic system disorders Hemoglobin	70.5% 55/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Leukocytes (total WBC)	75.6% 59/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Lymphopenia	78.2% 61/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Neutrophils/granulocytes (ANC/AGC)	64.1% 50/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Platelets	32.1% 25/78 Adverse events were not collected/monitored "per Arm/Group"
Cardiac disorders Supraventricular and nodal arrhythmia, Sinus bradycardia	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Cardiac disorders Supraventricular and nodal arrhythmia, Sinus tachycardia	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Cardiac disorders Cardiac General - Other	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Hypertension	15.4% 12/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Hypotension	9.0% 7/78 Adverse events were not collected/monitored "per Arm/Group"
Blood and lymphatic system disorders Coagulation - Other	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders INR (International Normalized Ratio of prothrombin time)	7.7% 6/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders PTT (Partial Thromboplastin Time)	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Constitutional Symptoms - Other	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Fatigue (asthenia, lethargy, malaise)	73.1% 57/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	25.6% 20/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Insomnia	24.4% 19/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Rigors/chills	16.7% 13/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Weight loss	64.1% 50/78 Adverse events were not collected/monitored "per Arm/Group"
Injury, poisoning and procedural complications Burn	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	26.9% 21/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Dry skin	56.4% 44/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	7.7% 6/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Hyperpigmentation	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Hypopigmentation	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Injection site reaction/extravasation changes	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Nail changes	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Pruritus/itching	16.7% 13/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash/desquamation	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: acne/acneiform	70.5% 55/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation, Chemoradiation	42.3% 33/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation, Radiation	66.7% 52/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Ulceration	14.1% 11/78 Adverse events were not collected/monitored "per Arm/Group"
Injury, poisoning and procedural complications Wound complication, non-infectious	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Endocrine disorders Endocrine - Other	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Endocrine disorders Thyroid function, high (hyperthyroidism, thyrotoxicosis)	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Endocrine disorders Thyroid function, low (hypothyroidism)	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Anorexia	20.5% 16/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Constipation	46.2% 36/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Dehydration	26.9% 21/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Dental: dentures or prosthesis	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Dental: teeth	7.7% 6/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Diarrhea	20.5% 16/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Distension/bloating, abdominal	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	66.7% 52/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Dysphagia (difficulty swallowing)	71.8% 56/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Esophagitis	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Gastrointestinal - Other	20.5% 16/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Heartburn/dyspepsia	21.8% 17/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Hemorrhoids	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam), Larynx	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Mucositis/stomatitis (clinical exam), Oral cavity	46.2% 36/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam), Pharynx	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic), Oral cavity	61.5% 48/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (functional/symptomatic), Pharynx	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Nausea	57.7% 45/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Perforation, GI, Colon	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Salivary gland changes/saliva	32.1% 25/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Taste alteration (dysgeusia)	46.2% 36/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Typhlitis (cecal inflammation)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Ulcer, GI, Duodenum	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Ulcer, GI, Stomach	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Vomiting	33.3% 26/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Hemorrhage, GI, Anus	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Hemorrhage, GI, Oral cavity	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Renal and urinary disorders Hemorrhage, GU, Urinary NOS	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, Bronchopulmonary NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, Nose	14.1% 11/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, Pharynx	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, Respiratory tract NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Blood and lymphatic system disorders Hemorrhage/Bleeding - Other	10.3% 8/78 Adverse events were not collected/monitored "per Arm/Group"
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin without documented infection)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), Neck NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection - Other	44.9% 35/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Abdomen NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Foreign body	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Neck NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Upper aerodigestive NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with unknown ANC, Dental-tooth	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with unknown ANC, Foreign body (e.g., graft, implant, prosthesis, stent)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with unknown ANC, Neck NOS	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with unknown ANC, Skin (cellulitis)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Opportunistic infection associated with >=Grade 2 Lymphopenia	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Edema: head and neck	12.8% 10/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Edema: limb	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Blood and lymphatic system disorders Lymphatics - Other	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	47.4% 37/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	44.9% 35/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	70.5% 55/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Alkaline phosphatase	16.7% 13/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Bicarbonate, serum-low	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Bilirubin (hyperbilirubinemia)	7.7% 6/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	10.3% 8/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	44.9% 35/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Cholesterol, serum-high (hypercholesteremia)	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Investigations Creatinine	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	76.9% 60/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	6.4% 5/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	23.1% 18/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	21.8% 17/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Metabolic/Laboratory - Other	29.5% 23/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	20.5% 16/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	20.5% 16/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	24.4% 19/78 Adverse events were not collected/monitored "per Arm/Group"
Renal and urinary disorders Proteinuria	6.4% 5/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	64.1% 50/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Cervical spine-range of motion	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Fibrosis-deep connective tissue	7.7% 6/78 Adverse events were not collected/monitored "per Arm/Group"
Injury, poisoning and procedural complications Fracture	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Joint-function	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy), Extremity-upper	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	20.5% 16/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Osteonecrosis (avascular necrosis)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Osteoporosis	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Soft tissue necrosis, Neck	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Trismus (difficulty, restriction or pain when opening mouth)	15.4% 12/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Cognitive disturbance	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Confusion	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Dizziness	11.5% 9/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Memory impairment	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Mental status	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Mood alteration, Agitation	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Mood alteration, Anxiety	14.1% 11/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Mood alteration, Depression	10.3% 8/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Neurology - Other	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Neuropathy: sensory	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Psychosis (hallucinations/delusions)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Seizure	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Syncope (fainting)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Tremor	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Eye disorders Dry eye syndrome	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Eye disorders Vision-blurred vision	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Eye disorders Vision-flashing lights/floaters	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Eye disorders Vision-photophobia	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Eye disorders Watery eye (epiphora, tearing)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Pain - Other	56.4% 44/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Pain, Abdomen NOS	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Pain, Back	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pain, Chest/thorax NOS	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Pain, Dental/teeth/peridontal	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Pain, Esophagus	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Ear and labyrinth disorders Pain, External ear	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Pain, Extremity-limb	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Pain, Face	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Pain, Head/headache	35.9% 28/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Pain, Joint	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pain, Larynx	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Pain, Muscle	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Pain, Neck	17.9% 14/78 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Pain, Oral cavity	25.6% 20/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Pain, Pain NOS	20.5% 16/78 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Pain, Skin	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pain, Throat/pharynx/larynx	44.9% 35/78 Adverse events were not collected/monitored "per Arm/Group"
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pain, Tumor pain	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Aspiration	5.1% 4/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Atelectasis	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Cough	17.9% 14/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	9.0% 7/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	2.6% 2/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Hypoxia	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	0.00% 0/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	9.0% 7/78 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	38.5% 30/78 Adverse events were not collected/monitored "per Arm/Group"
Renal and urinary disorders Renal/Genitourinary - Other	3.8% 3/78 Adverse events were not collected/monitored "per Arm/Group"
Reproductive system and breast disorders Erectile dysfunction	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Reproductive system and breast disorders Libido	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Reproductive system and breast disorders Sexual/Reproductive Function - Other	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
General disorders Flu-like syndrome	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Phlebitis (including superficial thrombosis)	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Thrombosis/thrombus/embolism	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Vascular - Other	1.3% 1/78 Adverse events were not collected/monitored "per Arm/Group"

Additional Information

Julie Bauman, MD

University of Pittsburgh

Phone: 412-623-7833

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place