Trial Outcomes & Findings for Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer (NCT NCT00786682)
NCT ID: NCT00786682
Last Updated: 2023-08-14
Results Overview
We will use a two-stage optimal Simon's design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The "expected" sample size of the trial is 23.5 with the null response rate of 50%.
TERMINATED
PHASE2
11 participants
4 years
2023-08-14
Participant Flow
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and a community hospital in New Jersey, part of the CINJ Oncology Group, from February 2009 through August 2010.
Participant milestones
| Measure |
Docetaxel and Hydroxychloroquine
Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel and Hydroxychloroquine
n=11 Participants
Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Upon reviewing response data for the first 8 patients, we noted that there were no responses thus far. As per the two-stage optimal Simon's design, we would need 8 responses in 15 patients to proceed to stage 2 but we would not have crossed that threshold. The study was stopped due to lack of improved efficacy compared to historical controls.
We will use a two-stage optimal Simon's design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The "expected" sample size of the trial is 23.5 with the null response rate of 50%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 yearsPopulation: Study was terminated prematurely and insufficient data was collected to assess this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 yearsPopulation: Study was terminated prematurely and insufficient data was collected to assess this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Docetaxel and Hydroxychloroquine
Serious adverse events
| Measure |
Docetaxel and Hydroxychloroquine
n=11 participants at risk
Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Hemorrhage, GU - Bladder
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Nervous system disorders
Neuropathy: sensory
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection
|
18.2%
2/11 • Number of events 2 • 3 years
|
Other adverse events
| Measure |
Docetaxel and Hydroxychloroquine
n=11 participants at risk
Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle
Drug: hydroxychloroquine 200 mg twice daily
A cycle is defined as an interval of 21 days.
|
|---|---|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
36.4%
4/11 • Number of events 6 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
27.3%
3/11 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain - Back
|
18.2%
2/11 • Number of events 3 • 3 years
|
|
General disorders
Pain - Joint
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
General disorders
Pain - Abdomen NOS
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain - Chest wall
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain - Chest/thorax NOS
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain - Dental/teeth/peridontal
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain - Extremity-limb
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain - Head/headache
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain - Neck
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
18.2%
2/11 • Number of events 7 • 3 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Nervous system disorders
Neuropathy: sensory
|
27.3%
3/11 • Number of events 4 • 3 years
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiac General
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Cardiac disorders
Hypertension
|
9.1%
1/11 • Number of events 3 • 3 years
|
|
Endocrine disorders
Hot flashes/flushes
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Hemorrhage, GU - Bladder
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Hemorrhage, GU - Urinary NOS
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Edema: limb
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory )
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
9.1%
1/11 • Number of events 1 • 3 years
|
Additional Information
Dr. Mark Stein
Cancer Institute of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place