Prostate CancerPhase 2NCT00786682
Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer
A Phase 2 study testing docetaxel and hydroxychloroquine in people with Prostate Cancer, run by University of Medicine and Dentistry of New Jersey at 7 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help docetaxel work better and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel and hydroxychloroquine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2008to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Metastatic disease, as demonstrated by bone scan and/or CT scan of the abdomen/pelvis
- Must demonstrate disease progression after initial hormone therapy (including bicalutamide and flutamide)
- No prior chemotherapy allowed
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- ANC > 1,500/μL
- Hemoglobin > 10 g/dL
- Platelet count > 100,000/mm^3
- Serum creatinine < 2.0 mg/dL or creatinine clearance > 50 mL/min
- Total bilirubin normal
- SGOT and/or SGPT < 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 2.5 times ULN
- Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- No second primary malignancy except for most in situ carcinomas (e.g., adequately treated nonmelanoma carcinoma of the skin) or other malignancy treated ≥ 5 years ago with no evidence of recurrence
- No history or symptoms of cardiovascular disease, including any of the following:
- NYHA class II-IV cardiovacular disease within the past 6 months
- Coronary artery disease
- Arrhythmias
- Conduction defects with risk of cardiovascular instability
- Uncontrolled hypertension
- Clinically significant pericardial effusion
- Congestive heart failure
- No uncontrolled intercurrent illness including ongoing active infection that would limit compliance with study requirements
- No rheumatoid arthritis or systemic lupus erythematosus requiring treatment
- No psoriasis or porphyria
- No known HIV infection
- No hypersensitivity to 4-aminoquinoline compounds, including hydroxychloroquine sulfate, chloroquine phosphate, and amodiaquine
- No retinal or vision changes from prior 4-aminoquinoline compound use
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No known G-6PDH deficiency
- Neurotoxicity ≤ grade 1
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No prior taxane
- At least 4 weeks since prior therapy (including surgery and radiotherapy)
- At least 1 week since prior herbal supplements
- At least 6 weeks since prior bicalutamide
- At least 4 weeks since prior flutamide
- No current hydroxychloroquine for treatment or prophylaxis
- Prior hydroxychloroquine allowed
- No other concurrent investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy
- Concurrent luteinizing-hormone releasing-hormone agonists allowed
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Mountainside Hospital
Montclair, New Jersey, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
St. Peters University Hospital
New Brunswick, New Jersey, 08903
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Overlook Hospital
Summit, New Jersey, 07901
About this study
Official title: A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help docetaxel work better and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with hydroxychloroquine works in treating patients with metastatic prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the antitumor activity, in terms of tumor response rate, of docetaxel in combination with hydroxychloroquine in patients with metastatic, hormone-refractory, chemotherapy-naive prostate cancer.
Secondary
- To measure time to disease progression and overall survival.
- To determine the feasibility and safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral hydroxychloroquine twice daily on days 1-21 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days (up to 6 courses with docetaxel) in the absence of disease progression or unacceptable toxicity.
- Conditions
- Prostate Cancer
- Being tested
- docetaxel, hydroxychloroquine
- Keywords
- stage IV prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel and Hydroxychloroquine | Experimental | 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. Receives: Drug: docetaxel; Drug: hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.
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%.
Measured: 4 years
Secondary outcomes (2)
Time to Disease Progression
Measured: 10 years
Overall Survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Lack of improved efficacy compared to historical controls, competing studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Stein, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786682
- Sponsor's protocol ID
- CDR0000617998
- Other IDs
- P30CA072720, CINJ-080805
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2008
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00786682
- Acronym / sponsor ID
- CDR0000617998
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of improved efficacy compared to historical controls, competing studies
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help docetaxel work better and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with hydroxychloroquine works in treating patients with metastatic prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the antitumor activity, in terms of tumor response rate, of docetaxel in combination with hydroxychloroquine in patients with metastatic, hormone-refractory, chemotherapy-naive prostate cancer.
Secondary
- To measure time to disease progression and overall survival.
- To determine the feasibility and safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral hydroxychloroquine twice daily on days 1-21 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days (up to 6 courses with docetaxel) in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and Hydroxychloroquine | Experimental | Drug: docetaxel, Drug: hydroxychloroquineDrug: 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | Docetaxel and Hydroxychloroquine |
| hydroxychloroquine | Drug | Docetaxel and Hydroxychloroquine |
Primary outcome
Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.
Time frame: 4 years
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%.
2 secondary outcomes
Time to Disease Progression
Time frame: 10 years
Overall Survival
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Stein, MD principal investigator
Rutgers Cancer Institute of New Jersey
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and hydroxychloroquine in people with Prostate Cancer, run by University of Medicine and Dentistry of New Jersey at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.