Trial Outcomes & Findings for Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies (NCT NCT02985021)

Last Updated: 2021-08-05

Results Overview

Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)

Results posted on

2021-08-05

Participant milestones
Measure	Treatment (Docetaxel, Carboplatin) Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle. Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity. Carboplatin: Chemotherapy Docetaxel: Chemotherapy
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Treatment (Docetaxel, Carboplatin) Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle. Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity. Carboplatin: Chemotherapy Docetaxel: Chemotherapy
Overall Study Inability to comply with study procedures	1

Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies

Baseline characteristics by cohort
Measure	Treatment (Docetaxel, Carboplatin) n=2 Participants Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle. Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity. Carboplatin: Chemotherapy Docetaxel: Chemotherapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	2 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	2 participants n=5 Participants
Patients with metastatic resistant prostate cancer	2 Participants n=5 Participants

Timeframe: From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)

Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy

Outcome measures
Measure	Treatment (Docetaxel, Carboplatin) n=2 Participants Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle. Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity. Carboplatin: Chemotherapy Docetaxel: Chemotherapy
Percentage of Patients Achieving >= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria	2 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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