Trial Outcomes & Findings for Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer (NCT NCT00828308)

NCT ID: NCT00828308

Last Updated: 2022-03-08

Results Overview

Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: after 12 weeks of ixabepilone
• Results posted on: 2022-03-08

Participant Flow

First patient enrolled 2/11/09 and last patient enrolled was 3/30/11

Participant milestones

Measure	Ixabepilone Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

Baseline characteristics by cohort

Measure	Ixabepilone n=16 Participants Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 29 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: after 12 weeks of ixabepilone

Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone

Outcome measures

Measure	Ixabepilone n=16 Participants Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
Prostate-Specific Antigen (PSA) Response	14 participants

Adverse Events

Ixabepilone

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ixabepilone n=16 participants at risk Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
Investigations pneumonia (3) with normal ANC, post infuection bronchitis (3), wheezing (3)	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.

Other adverse events

Measure	Ixabepilone n=16 participants at risk Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
Investigations Constipation	37.5% 6/16 • Number of events 6 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations nasuea	18.8% 3/16 • Number of events 3 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations neuorapthy	81.2% 13/16 • Number of events 13 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations fatigue	68.8% 11/16 • Number of events 11 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations diarrhea	43.8% 7/16 • Number of events 7 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations taste alteration	18.8% 3/16 • Number of events 3 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations heartburn	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations pain	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations dehydration	18.8% 3/16 • Number of events 3 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations insomnia	25.0% 4/16 • Number of events 4 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations wt loss	18.8% 3/16 • Number of events 3 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations rash/pruritus	12.5% 2/16 • Number of events 2 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations anorexia	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations hyperpigmentation	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations abdominal cramping/pain	25.0% 4/16 • Number of events 4 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations dysphagia	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations urinary frequency	12.5% 2/16 • Number of events 2 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations allergic reaction/hypersensitivity reaction	18.8% 3/16 • Number of events 3 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations edema	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations rhinitis	12.5% 2/16 • Number of events 2 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations depression	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations infection	25.0% 4/16 • Number of events 4 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations alopecia	31.2% 5/16 • Number of events 5 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations HTN	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations shortness of breath	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations headache	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations muscle aches/myalgia	12.5% 2/16 • Number of events 2 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations wheezing	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations cough	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations WBC	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations ANC	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations HGB	12.5% 2/16 • Number of events 2 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations pain-joint	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations sore throat	18.8% 3/16 • Number of events 3 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations flushing	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations flatulence	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations mood	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations pain-mouth	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations pain-muscle	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.
Investigations hoarseness	6.2% 1/16 • Number of events 1 • Toxicities collected during treatment and approximately 30 days post last dose of drug (approximately 5 months). Of note, the adverse events posted are all AEs patient's experienced and do not equate to toxicities confirmed as related to treatment.

Additional Information

Anthony Mega, MD

BrUOG

Phone: 4018633000

Email: BrUOG@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place