Clinical trial · Interventional
A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
NCT00675545CI-TRIAL-00006643completedPhase 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)
The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory 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 |
|---|---|---|---|
| Hormone-Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel and prednisolone
- description
- Patients in study will receive both chemotherapeutic agents on day 1 and day 8 of every 21-day cycle as described below: * Docetaxel 30 mg/m2 over 1 hour IV infusion, followed by * Carboplatin (AUC 2) over 1 hour IV infusion * Additonal medication required: IV Dexamethasone 10 mg followed by PO dexamethasone 4 mg 8 hourly x 4 doses, starting 12 hours after starting iv docetaxel.
- interventionNames
- Drug: Docetaxel, Carboplatin
Primary outcomes (1)
- measure
- efficacy of docetaxel plus carboplatin
- timeFrame
- evaluated every 3 cycles (9 weeks)
- description
- The primary endpoint of the study is best overall response (complete or partial response) obtained from measurable target lesion or PSA, as defined using the modified RECIST criteria.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. 2. At the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per RECIST criteria or non- measurable disease (i.e. positive bones scan) and PSA \> 5 ng/mm3. 3. Disease progression following androgen deprivation therapy. 4. Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3). 5. Serum testosterone levels \< 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy. 6. No use of an antiandrogen for at least 4 weeks. 7. Have not been treated with chemotherapy before. 8. ECOG performance status of \<= 2. 9. Laboratory criteria for entry: * White blood cell (WBC) =\> 3000/mm3 * Platelets =\> 100,000/mm3 * AST \< 2.5 x upper limit of normal * Calculated CCT of =\> 40 ml/min 10. Signed informed consent form. 11. Age: 30 years old and above Exclusion Criteria: 1. Significant peripheral neuropathy defined as grade 2 or higher. 2. Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium). 3. Concomitant chemotherapy or investigational agents.
References
Publications (2)
- BACKGROUNDTannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720. PMID 15470213
- BACKGROUNDOh WK, Halabi S, Kelly WK, Werner C, Godley PA, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B 99813. A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813. Cancer. 2003 Dec 15;98(12):2592-8. doi: 10.1002/cncr.11829. PMID 14669278