Trial Outcomes & Findings for Docetaxel and Carboplatin in Treating Patients With Metastatic, Castration Resistant Prostate Cancer Containing Inactivated Genes in the BRCA 1/2 Pathway (NCT NCT02598895)
NCT ID: NCT02598895
Last Updated: 2022-11-17
Results Overview
Proportion of patients with PSA decline by 50% from baseline according to Prostate Cancer Working Group 2 (PCWG2) criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Until disease progression or unacceptable toxicity, assessed up to 35 days after the last dose of study medication
Results posted on
2022-11-17
Participant Flow
Participant milestones
| Measure |
Treatment (Docetaxel, Carboplatin)
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
PSA50
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel and Carboplatin in Treating Patients With Metastatic, Castration Resistant Prostate Cancer Containing Inactivated Genes in the BRCA 1/2 Pathway
Baseline characteristics by cohort
| Measure |
Treatment (Docetaxel, Carboplatin)
n=14 Participants
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 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
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression or unacceptable toxicity, assessed up to 35 days after the last dose of study medicationPopulation: Patients treated with docetaxel and carboplatin.
Proportion of patients with PSA decline by 50% from baseline according to Prostate Cancer Working Group 2 (PCWG2) criteria
Outcome measures
| Measure |
Treatment (Docetaxel, Carboplatin)
n=14 Participants
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Proportion of Patients With PSA Decline by 50% From Baseline
achieved PSA50
|
9 Participants
|
|
Proportion of Patients With PSA Decline by 50% From Baseline
did not achieve PSA50
|
5 Participants
|
Adverse Events
Treatment (Docetaxel, Carboplatin)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Docetaxel, Carboplatin)
n=14 participants at risk
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
28.6%
4/14 • Number of events 9 • Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
7.1%
1/14 • Number of events 1 • Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • Number of events 2 • Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
7.1%
1/14 • Number of events 1 • Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
7.1%
1/14 • Number of events 1 • Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
|
|
Immune system disorders
Anaphylaxis
|
7.1%
1/14 • Number of events 1 • Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.1%
1/14 • Number of events 1 • Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.
The investigator was responsible for ensuring that all non-serious grade 3 and above non-serious adverse events (as defined in Section 6.7.1 and as further specified below) observed by the investigator or reported by subjects were collected and recorded in the CRF. Source documents may have included the subjects' medical records, patient diaries or study-specific worksheets. Recording for all events were done in a concise manner using standard, acceptable medical terms.
|
Additional Information
Dr. Heather Cheng
University of Washington/Fred Hutchinson Cancer Center
Phone: 206-606-7416
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place