Trial Outcomes & Findings for Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer (NCT NCT00658697)

Last Updated: 2017-05-25

Results Overview

For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA \> 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA \>2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

participants were followed for the duration of the study, an average of 2 years

Results posted on

2017-05-25

Participant Flow

42 patients were enrolled between June 2, 2008 to December 14, 2010 at Dana Farber Cancer Institute and University of Michigan. One patient never started any study treatment, and was excluded from analysis.

Participant milestones

Participant milestones
Measure	Docetaxel, Bevacizumab, and ADT Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel, Bevacizumab, and Androgen Deprivation Therapy (ADT) n=41 Participants Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles Androgen deprivation therapy (ADT) or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: participants were followed for the duration of the study, an average of 2 years

Outcome measures

Outcome measures
Measure	Docetaxel, Bevacizumab, and ADT n=41 Participants Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)	98 percentage of participants with data Interval 93.0 to 100.0

SECONDARY outcome

Timeframe: 1 year + 3 month off last ADT injection

Population: The analysis comprised of all patients received at least one treatment and had PSA data available\* for the assessment of PSA responses at one year after completing ADT \*Note excluded 5 patients started treatments but had no PSA information at one year.

The PSA response was defined using two cut-offs: PSA \<0.2 ng/mL or PSA \<0.01 ng/mL at the one year after completion of ADT.

Outcome measures

Outcome measures
Measure	Docetaxel, Bevacizumab, and ADT n=36 Participants Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Proportion of Patients With PSA Responses at One Year After the Completion of ADT PSA <0.2 ng/mL	44 percentage of participants with data Interval 28.0 to 62.0
Proportion of Patients With PSA Responses at One Year After the Completion of ADT PSA <=0.01 ng/mL	25 percentage of participants with data Interval 12.0 to 42.0

SECONDARY outcome

Timeframe: participants were followed for the duration of the study, an average of 2 years

Population: the analysis dataset is comprised of all treated patients

Outcome measures

Outcome measures
Measure	Docetaxel, Bevacizumab, and ADT n=41 Participants Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Time to PSA Progression (TTP)	27.5 months Interval 26.0 to 38.0

SECONDARY outcome

Timeframe: 2 years

Population: All treated patients with assessable testosterone level data

Testosterone recovery was defined as \>100 or within DFCI institute normal range (240-950) at one year after the completion of ADT

Outcome measures

Outcome measures
Measure	Docetaxel, Bevacizumab, and ADT n=35 Participants Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Testosterone Recovery Testosterone >=100 ng/mL	83 percentage of participants with data Interval 66.0 to 93.0
Testosterone Recovery Testosterone >=240 ng/mL	35 percentage of participants with data Interval 31.0 to 66.0

SECONDARY outcome

Timeframe: Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years

Population: All patients received at least one study therapies

Treatment related adverse events were graded based on CTCAE v. 3.0.

Outcome measures

Outcome measures
Measure	Docetaxel, Bevacizumab, and ADT n=41 Participants Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Toxicity Grade 3 treatment related AE	16 participants
Toxicity Grade 4 treatment related AEs	5 participants

Adverse Events

Docetaxel, Bevacizumab, and ADT

Serious events: 21 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel, Bevacizumab, and ADT n=41 participants at risk Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Nervous system disorders Leukoencephalopathy	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Blood and lymphatic system disorders Hematologic-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Blood and lymphatic system disorders Thrombotic microangiopathy	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Blood and lymphatic system disorders Febrile neutropenia	12.2% 5/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Cardiac disorders Left ventricular systolic dysfunction	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Lower GI= hemorrhage NOS	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Stomach= hemorrhage	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Injection site reaction	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Immune system disorders Allergic reaction	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Perforation= appendix	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Infection Gr0-2 neut= muscle	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Infection Gr0-2 neut= wound	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Leukocytes	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Neutrophils	26.8% 11/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Metabolism and nutrition disorders Hyponatremia	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Nervous system disorders Neurologic-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Renal and urinary disorders Proteinuria	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Hand-foot reaction	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Vascular disorders Hypertension	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.

Other adverse events

Other adverse events
Measure	Docetaxel, Bevacizumab, and ADT n=41 participants at risk Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Docetaxel Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed
Cardiac disorders Sinus arrhythmia	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Endocrine disorders Endocrine-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Eye disorders Vision-blurred	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Eye disorders Tearing	22.0% 9/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Constipation	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Diarrhea w/o prior colostomy	19.5% 8/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Dry mouth	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Flatulence	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Gastritis	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Dyspepsia	12.2% 5/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Hemorrhoids	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Muco/stomatitis by exam= oral cavity	14.6% 6/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Blood and lymphatic system disorders Hemoglobin	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	19.5% 8/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Nausea	31.7% 13/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Vomiting	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders GI-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Anus= hemorrhage	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Oral cavity= hemorrhage	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Rectum= hemorrhage	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Abdomen= pain	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Oral cavity= pain	7.3% 3/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Gastrointestinal disorders Stomach= pain	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Fatigue	85.4% 35/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Fever w/o neutropenia	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Rigors/chills	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Edema limb	17.1% 7/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Edema trunk/genital	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Pain-other	7.3% 3/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
General disorders Flu-like syndrome	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Immune system disorders Allergic reaction	19.5% 8/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Infection Gr0-2 neut= oral cavity	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Infection Gr0-2 neut= skin	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Infection w/ unk ANC dental-tooth	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Infection w/ unk ANC upper airway NOS	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Infections and infestations Infection-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Leukocytes	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Neutrophils	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Weight gain	7.3% 3/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Weight loss	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Alkaline phosphatase	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations ALT= SGPT	12.2% 5/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations AST= SGOT	14.6% 6/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Investigations Creatinine	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Metabolism and nutrition disorders Anorexia	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Metabolism and nutrition disorders Dehydration	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Metabolism and nutrition disorders Hyperkalemia	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Musculoskeletal and connective tissue disorders Muscular/skeletal hypoplasia	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Musculoskeletal and connective tissue disorders Back= pain	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Musculoskeletal and connective tissue disorders Buttock= pain	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Musculoskeletal and connective tissue disorders Extremity-limb= pain	7.3% 3/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Musculoskeletal and connective tissue disorders Joint= pain	14.6% 6/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Musculoskeletal and connective tissue disorders Muscle= pain	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Nervous system disorders Taste disturbance	46.3% 19/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Nervous system disorders Mental status	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Nervous system disorders Neuropathy CN V jaw / face-sensory	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Nervous system disorders Neuropathy-sensory	29.3% 12/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Nervous system disorders Neurologic-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Nervous system disorders Head/headache	29.3% 12/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Psychiatric disorders Insomnia	12.2% 5/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Psychiatric disorders Depression	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Psychiatric disorders Libido	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Renal and urinary disorders Proteinuria	7.3% 3/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Renal and urinary disorders Incontinence urinary	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Renal and urinary disorders Urinary frequency/urgency	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Reproductive system and breast disorders Breast= pain	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Reproductive system and breast disorders Scrotum= pain	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Reproductive system and breast disorders Testicle= pain	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Reproductive system and breast disorders Erectile impotence	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Reproductive system and breast disorders Gynecomastia	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Reproductive system and breast disorders Sexual/Reproductive function-Other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Nose= hemorrhage	41.5% 17/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx= pain	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Cough	9.8% 4/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reaction	19.5% 8/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	7.3% 3/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Sweating	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Dry skin	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Alopecia	46.3% 19/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Nail changes	26.8% 11/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Rash/desquamation	4.9% 2/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Hand-foot reaction	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Skin and subcutaneous tissue disorders Skin-other	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Vascular disorders Hypertension	39.0% 16/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Vascular disorders Flushing	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Vascular disorders Hot flashes	75.6% 31/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.
Vascular disorders Hematoma	2.4% 1/41 • Assessed each cycle throughout treatment form time of first dose and up to day 30 post-treatment, up to 2 years.

Additional Information

Rana R. McKay, MD

DFCI

Phone: 6176323237

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place