Trial Outcomes & Findings for Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer (NCT NCT00456989)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

39 participants

Primary outcome timeframe

2 years

Results posted on

2019-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Taxotere and Doxil Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively. Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Taxotere and Doxil n=39 Participants Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively. Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
Age, Customized >=18	39 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	39 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 years

Population: There is no data to report. Data for this trial was not analyzed, the PI left institution.

Data not analyzed, PI left institution

Outcome measures

Outcome data not reported

Adverse Events

Taxotere and Doxil

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Taxotere and Doxil n=39 participants at risk Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively. Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.
Infections and infestations Bacterial meningitis	2.6% 1/39 • Number of events 1
General disorders Fatique	5.1% 2/39 • Number of events 2
Gastrointestinal disorders Diarrhea	2.6% 1/39 • Number of events 1
General disorders Fever	2.6% 1/39 • Number of events 1
General disorders Bleeding	5.1% 2/39 • Number of events 2
General disorders Mouth pain	2.6% 1/39 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

University of Louisville, James Graham Brown Cancer Center Clinical Trials

University of Louisville, James Graham Brown Cancer Center

Phone: 502-562-3429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place