No registrations found.
ID
Source
Brief title
Health condition
Hormone refractory prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression-free survival
Secondary outcome
1. Safety and tolerability;
2. Magnitude and duration of PSA response;
3. Tumor response in measurable direase;
4. Overall survival;
5. Quality of life.
Background summary
Docetaxel has been accepted as the new standard for treatment of patients with metastatic hormone-refractory prostate cancer (HRPC). Moreover, docetaxel-based chemotherapy is the reference treatment for development of new treatment options in HRPC. Few treatment options are available for patients who progressed on first line docetaxel-based chemotherapy (CT). While single-agent carboplatin has modest activity in HRPC, carboplatin chemotherapy could induce a synergistic effect when combined with taxanes in patients resistant to taxane-based chemotherapy. The combination of docetaxel (60 mg/m²) plus carboplatin (AUC4) has demonstrated clinical activity in patients who definitively progressed after docetaxel-based therapy. In this study the efficacy of docetaxel/carboplatin combination therapy relative to docetaxel monotherapy will be evaluated in docetaxel-sensitive patients who progressed on first line docetaxel-based CT.
Study objective
The progressionfree survival during treatment with carboplatin plus docetaxel is significantly better compared to standard treatment with docetaxel monotherapy.
Study design
Every 9 weeks. Measurements through PSA, chest X-ray or CT scan, abdominal/pelvic CT scan and bone scan.
Intervention
Arm A: Docetaxel 75 mg/m² q3 weeks + prednisone 5 mg bid;
Arm B: Docetaxel 60 mg/m² q3 weeks + prednisone 5 mg bid + carboplatin AUC
(4) q3 weeks.
Treatment in both arms will be continued until progression, unacceptable toxicity or 10 courses (whichever comes first).
De Boelelaan 1117
Winald Gerritsen
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4444356
rsc@rsconsultancy.nl
De Boelelaan 1117
Winald Gerritsen
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4444356
rsc@rsconsultancy.nl
Inclusion criteria
1. Histologically proven prostate adenocarcinoma;
2. Hormone refractory prostate cancer;
3. Patients must have had PSA and/or clinical response and progression free for >3 months on first line chemotherapy with docetaxel for HRPC;
4. Patients must have progressed on prior chemotherapy with docetaxel; progression at study entry is defined as (confirmed) PSA progression and/or objective tumor progression whichever comes first (see 6.2.3);
5. Last PSA value ≥ 5 ng/ml within 2 weeks prior to registration (HYBRITECH equivalent);
6. Patients without surgical castration must continue on LHRH agonist therapy;
7. Age ≥ 18 years;
8. ECOG performance status ≤2;
9. Gleason score ≥ 7;
10. Adequate haematological functions as assessed by neutrophils >1,5x109/, platelets >100x109/L;
11. Adequate liver function as assessed by bilirubin <1,5 times the upper limit of the normal range and transaminases <5 times the upper limit of normal range in case of liver metastases and <2,5 times the upper limit of the normal range in absence of liver metastases;
12. Adequate renal function as assessed by serum creatinine <150 µmol/l (<1,7 mg/dl);
13. Psychological, familial and geographical conditions must permit adequate medical follow up and compliance with the study protocol;
14. Written informed consent according to ICH-GCP.
Exclusion criteria
1. More than 1 line of chemotherapy;
2. No prior platinum allowed;
3. Radiotherapy within 2 weeks prior to treatment start;
4. Concurrent treatment with other experimental drugs;
5. Evidence of symptomatic brain and leptomeningeal metastatic disease;
6. Previous or concurrent malignancies at other sites (except basal squamous cell carcinoma of the skin);
7. Uncontrolled systemic disease or infection;
8. Severe concomitant disease for which chemotherapy is contra-indicated.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2923 |
| NTR-old | NTR3070 |
| CCMO | NL27431.029.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35127 |