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Docetaxel met carboplatine versus docetaxel, een gerandomiseerde fase 2 studie bij patiŽnten met hormoonongevoelig prostaatkanker na eerdere respons op docetaxel-bevattende chemotherapie: RECARDO STUDIE.


- candidate number10351
- NTR NumberNTR3070
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2011
- Secondary IDsNL27431.029.09 CCMO
- Public TitleDocetaxel met carboplatine versus docetaxel, een gerandomiseerde fase 2 studie bij patiŽnten met hormoonongevoelig prostaatkanker na eerdere respons op docetaxel-bevattende chemotherapie: RECARDO STUDIE.
- Scientific TitleA randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY.
- ACRONYMRECARDO
- hypothesisThe progressionfree survival during treatment with carboplatin plus docetaxel is significantly better compared to standard treatment with docetaxel monotherapy.
- Healt Condition(s) or Problem(s) studiedHormone refractory prostate cancer
- Inclusion criteria1. 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 Ķmol/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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-jun-2012
- Target number of participants150
- InterventionsArm A: Docetaxel 75 mg/m≤ q3 weeks + prednisone 5 mg bid;
Arm B: Docetaxel 60 mg/m≤ 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).
- Primary outcomeProgression-free survival
- Secondary outcome1. Safety and tolerability;
2. Magnitude and duration of PSA response;
3. Tumor response in measurable direase;
4. Overall survival;
5. Quality of life.
- TimepointsEvery 9 weeks. Measurements through PSA, chest X-ray or CT scan, abdominal/pelvic CT scan and bone scan.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. Winald Gerritsen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Winald Gerritsen
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryDocetaxel 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/m≤) 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.
- Main changes (audit trail)
- RECORD19-sep-2011 - 5-okt-2011


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