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The trial was stopped for futility in view of the results of the interim analysis
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Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant. Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin | Experimental | curcumine capsule |
|
| Placebo | Placebo Comparator | placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial). Progression was defined as an increase (of) injury (s) tumor (s) (RECIST) or an increase in PSA levels (≥ 25% and ≥ 2ng/ml increase) or the appearance of new lesions metastatic (at least 2 new lesions for bone lesions). From date of randomization until the date of first documented progression or date of death from any cause | participants will be followed post treatment. From date of randomization until the date of first documented progression or date of death from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response | Evaluate the PSA response (50% decrease compared to the initial value) | From date of randomization until the date of first documented PSA progression or date of death from any cause |
| objective tumor response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la Chataigneraie | Beaumont | France | ||||
| Centre Jean Perrin |
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|
| Taxotere | Drug |
|
Evaluate the objective tumor response rate (CR + PR) by RECIST.
| participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months) |
| safety and tolerability | Assess the safety (adverse events) of the combination Taxotere/ curcumin. | patients will be followed for the duration of the treatment, an expected average of 4 months |
| Pain | Assess pain in the short questionnaire on pain (QCD) | participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment) |
| neuroendocrine markers | Assess serum neuroendocrine markers | participants will be followed for the duration of the treatment, an expected average of 4 months |
| Overall survival | Evaluate overall survival (between inclusion and death whatever the cause) | from date of randomization until the date of death from any cause |
| anti-angiogenic activity | Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin | participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months |
| compliance | Assess the compliance by curcumin treatment / placebo orally | patients will be followed for the duration of the treatment, an expected average of 4 months |
| Clermont-Ferrand |
| France |
| Centre Hospitalier Emile Roux | Le Puy-en-Velay | France |
| Institut Jean Godinot | Reims | France |
| ID | Term |
|---|---|
| D003474 | Curcumin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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