Clinical trial · Interventional
Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer
A Phase II Study of Docetaxel and Modulation of Autophagy With Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer
NCT00786682CI-TRIAL-00068788terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of improved efficacy compared to historical controls, competing studies
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| hydroxychloroquine | Drug | Hydroxychloroquine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel and Hydroxychloroquine
- description
- 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.
- interventionNames
- Drug: docetaxel
- Drug: hydroxychloroquine
Primary outcomes (1)
- measure
- Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.
- timeFrame
- 4 years
- description
- 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%.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.