Trial Outcomes & Findings for Sirolimus, Docetaxel, and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT02565901)
NCT ID: NCT02565901
Last Updated: 2021-10-01
Results Overview
Will be determined by the level of genetic expression of WNT16, IL6, or SFRP2 in tissue after chemotherapy (carboplatin/docetaxel) compared to background/baseline measurement. The primary metric of DDSP induction will be quantitative reverse transcription-polymerase chain reaction, which is quantitative, but in the event of ribonucleic acid degradation in sample processing, the alternative measure will be immunohistochemistry (0-2 scale of expression).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline up to day 21 after starting treatment
Results posted on
2021-10-01
Participant Flow
Participant milestones
| Measure |
Arm I (Sirolimus, Docetaxel, Carboplatin)
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Arm II (Sirolimus, Docetaxel, Carboplatin)
Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Phase 1 Group
Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
6
|
|
Overall Study
COMPLETED
|
11
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sirolimus, Docetaxel, and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Sirolimus, Docetaxel, Carboplatin)
n=11 Participants
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Arm II (Sirolimus, Docetaxel, Carboplatin)
n=11 Participants
Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Phase 1 Group
n=6 Participants
Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
75 years
n=7 Participants
|
73 years
n=5 Participants
|
72 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
28 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to day 21 after starting treatmentPopulation: Results do not exist. Because of COVID, the laboratory which would have performed the analysis was shut down for an entire year and inadequate funding exists for data analysis.
Will be determined by the level of genetic expression of WNT16, IL6, or SFRP2 in tissue after chemotherapy (carboplatin/docetaxel) compared to background/baseline measurement. The primary metric of DDSP induction will be quantitative reverse transcription-polymerase chain reaction, which is quantitative, but in the event of ribonucleic acid degradation in sample processing, the alternative measure will be immunohistochemistry (0-2 scale of expression).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 3 yearsSafety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data. Adverse events will then be quantified via CTCAE 4.0.
Outcome measures
| Measure |
Arm I (Sirolimus, Docetaxel, Carboplatin)
n=11 Participants
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Sirolimus: Given PO
|
Arm II (Sirolimus, Docetaxel, Carboplatin)
n=11 Participants
Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Phase 1 Group
n=6 Participants
Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
|
|---|---|---|---|
|
Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phases I and II)
|
2 Grade 3 or 4 AE
|
2 Grade 3 or 4 AE
|
0 Grade 3 or 4 AE
|
SECONDARY outcome
Timeframe: Baseline to up to 3 yearsPSA decline from the level at registration will be quantified for each patient and proportion of patients with PSA decline divided by the total number of patients enrolled in study will be described.
Outcome measures
| Measure |
Arm I (Sirolimus, Docetaxel, Carboplatin)
n=11 Participants
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Sirolimus: Given PO
|
Arm II (Sirolimus, Docetaxel, Carboplatin)
n=11 Participants
Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Phase 1 Group
n=6 Participants
Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
|
|---|---|---|---|
|
Percentage of Patients With Reduction in Prostate Specific Antigen According to the Prostate Cancer Working Group 2 (PCWG2) Criteria (Phases I and II)
|
36 Percent with PSA decline
|
36 Percent with PSA decline
|
50 Percent with PSA decline
|
Adverse Events
Arm I (Sirolimus, Docetaxel, Carboplatin)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm II (Sirolimus, Docetaxel, Carboplatin)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Sirolimus, Docetaxel, Carboplatin)
n=11 participants at risk
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30 minutes on day 1. Beginning in cycle 2 and continuing in subsequent cycles, patients also receive sirolimus PO on day -2. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Arm II (Sirolimus, Docetaxel, Carboplatin)
n=11 participants at risk
Patients receive sirolimus PO on day -2. Patients also receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Sirolimus: Given PO
|
Phase 1 Group
n=6 participants at risk；n=11 participants at risk
Patients treated with docetaxel, carboplatin and sirolimus in the phase 1 component of study
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
18.2%
2/11 • Number of events 2 • During time on study to 30 days after last therapy. This was up to 2 years.
CTCAE 4.0 definitions of adverse events were used. Patients were evaluated with complete blood counts and comprehensive panels with each cycle and as clinically indicated
|
18.2%
2/11 • Number of events 2 • During time on study to 30 days after last therapy. This was up to 2 years.
CTCAE 4.0 definitions of adverse events were used. Patients were evaluated with complete blood counts and comprehensive panels with each cycle and as clinically indicated
|
0.00%
0/6 • During time on study to 30 days after last therapy. This was up to 2 years.
CTCAE 4.0 definitions of adverse events were used. Patients were evaluated with complete blood counts and comprehensive panels with each cycle and as clinically indicated
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place