Clinical trial · Interventional
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together with thalidomide may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| estramustine phosphate sodium | Drug | Estramustine | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- PSA response
- measure
- Toxicity
Secondary outcomes (1)
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic disease
* Androgen-independent disease
* Clinically progressive disease documented by at least 1 of the following parameters:
* Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart
* PSA ≥ 5.0 ng/mL
* Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)
* At least 1 new lesion on bone scan
* Progressive measurable disease
* Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist
* No brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3\*
* Hemoglobin ≥ 7.5 g/dL\* NOTE: \*No transfusions within the past 2 weeks
Hepatic
* AST and ALT \< 2.5 times upper limit of normal (ULN)
* Bilirubin \< ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)
* Alkaline phosphatase ≤ 2.5 times ULN OR
* Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 40 mL/min
Cardiovascular
* No transient ischemic attacks or cerebrovascular accident within the past 2 years
* No myocardial infarction within the past 6 months
* No uncontrolled congestive heart failure
* No uncontrolled angina pectoris
* No thromboembolic disease
Other
* No peripheral neuropathy ≥ grade 2
* No cognitive impairment that would preclude study participation or giving informed consent
* No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma
* Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior thalidomide
Chemotherapy
* No prior docetaxel
* No prior estramustine
* No prior chemotherapy for metastatic prostate cancer
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* Recovered from prior radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent complementary or alternative therapy that would interact with study drugs
* No concurrent herbal or nutritional products or dietary supplements that would interact with study drugs
* No concurrent aprepitant as secondary prophylaxis or antiemetic treatmentReferences
Publications (1)
- BACKGROUNDSissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24. PMID 21106711