Clinical trial · Interventional
Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer
NCT00046826CI-TRIAL-00009892completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy.
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 (1)
- measure
- Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment
Secondary outcomes (2)
- measure
- Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit
- measure
- Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Prior treatment with androgen ablation including:
* Orchiectomy OR
* Luteinizing hormone-releasing hormone (LHRH) therapy (e.g., leuprolide)
* Patients on leuprolide must continue to receive the drug
* Prior nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide) required
* Metastatic disease with disease progression during androgen ablation, defined by at least 1 of the following:
* 2 consecutive increased prostate-specific antigen (PSA) levels measured at least 1 week apart
* More than 25% increase in bidimensionally measurable soft tissue metastases
* 20% increase in the sum of the baseline sum of longest diameter of measurable lesions
* Appearance of new lesions
* Appearance of new foci on a radionuclide bone scan
* PSA greater than 10 ng/dL
* Testosterone no greater than 50 ng/mL (castrate level)
* No CNS metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Karnofsky 70-100%
Life expectancy:
* More than 16 weeks
Hematopoietic:
* WBC greater than 3,500/mm3
* Absolute neutrophil count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3
* Hemoglobin at least 8 g/dL
Hepatic:
* AST and/or ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
* Alkaline phosphatase no greater than 4 times ULN if AST/ALT no greater than ULN
* Bilirubin no greater than ULN
Renal:
* Creatinine less than 2.2 mg/dL
Cardiovascular:
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart disease
* No history of arterial or venous thrombosis
* No cerebrovascular accident within the past year
Pulmonary:
* No history of pulmonary embolism
Other:
* Fertile patients must use effective contraception during and for 4 weeks after study
* No peripheral neuropathy grade 2 or greater
* No active infection
* No serious concurrent medical illness that would preclude study
* No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No other prior or concurrent active malignancy within the past 2 years except non-melanoma skin cancers
* No other medical condition or reason that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for prostate cancer
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and continued evidence of disease progression (rising PSA)
* Prior steroids for prostate cancer allowed
* No concurrent steroids except for pre-medication for docetaxel
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
Other:
* No concurrent herbal supplements to treat prostate cancerReferences
Publications (1)
- RESULTFrank RC, Coscia A, Versea L, et al.: Low dose docetaxel, estramustine and thalidomide followed by maintenance thalidomide for the treatment of hormone refractory prostate cancer (HRPC): a phase II community based trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4681, 426s, 2004.