Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression free survival.
Secondary outcome
Tolerability, safety, PSA and tumor response, survival, QoL.
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 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
Primary objectives:
* Progression-free survival (PFS) defined as either of the following
occurrences, whichever comes first:
o PSA progression
o Progressive disease according to RECIST when measurable disease
Secondary objectives:
* Toxicity profile.
* PSA response and duration of PSA response.
* Objective tumor response when measurable disease.
* Survival.
* QoL.
Study design
Multicenter randomized, open-label, national phase II study with parallel
design. Randomization (1:1) to:
1. Arm A: docetaxel 75 mg/m² q3 weeks + prednisone 5 mg bid
2. Arm B: docetaxel 60 mg/m² q3 weeks + prednisone 5 mg bid + carboplatin AUC
(4) q3 weeks
Treatment in both arms will be until progression or unacceptable toxicity
(maximum 10 courses).
Pilot fase: Forty patients will be randomized (20 patients per arm). PSA
response (* 50%) must occur in at least 6 patients in this pilot. Toxicity in
both arms must be comparable and grade 3/4 non-haematological toxicity may not
be >10% and/or febrile neutropenia must not occur in more than 3 patients in
both arms.
Formal interim analysis after 75 patiens.
Follow-up 15 months.
150 patients. Planned inclusion: approx. 70 patients per year.
Intervention
Treatment with combine carboplatin and docetaxel or docetaxel alone.
Study burden and risks
Risk: Adverse effects of combined carboplatin and docetaxel or of docetaxel
alone.
Burden: The study is in line with current regular treatment in terms of visits
and procedures: hematology, biochemistry and PSA q3 weeks, imaging q9 weeks.
For study purposes only the QoL questionnaire (Functional Assessment of Cancer
Therapy*Prostate, FACT-P) is filled in q3 weeks.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. 18 years and above.
2. Histologically proven hormone refractory prostate adenocarcinoma.
3. PSA and/or clinical response on prior docetaxel-based chemotherapy with a progression free interval of over 3 months.
4. Last PSA value * 5 ng/ml within 2 weeks prior to registration (HYBRITECH equivalent)
5. Patients without surgical castration must continue on LHRH agonist therapy
6. ECOG performance status * 2
7. Gleason score 8-10
8. Adequate haematological, liver and renal function.
Exclusion criteria
1. More than 1 line of chemotherapy.
2. Prior platinum chemotherapy.
3. Radiotherapy within 2 weeks prior to treatment start.
4. Uncontrolled hypercalcemia.
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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov, registratienummer nog niet bekend |
| EudraCT | EUCTR2007-004335-39-NL |
| CCMO | NL27431.029.09 |
| OMON | NL-OMON27233 |