Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Antirheumatic Agents

Analgesics

Hypoglycemic Agents

Amino Acids

Dexamethasone

Hormones

Dexamethasone acetate

BB 1101

Etoricoxib

Pioglitazone

Imatinib Mesylate

Treosulfan

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Tyrosine

STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

imatinib mesylate

Treosulfane

etoricoxib

pioglitazone

dexamethasone

Novartis Pharmaceuticals

The purpose of this study is to evaluate the efficacy, tolerability and safety of a multi-targeted therapy in patients with hormone-refractory prostate cancer.

Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer

A Single Stage Phase II, Multi-centre, Open Label Study of Imatinib in Combination With Pioglitazone, Etoricoxib, Dexamethasone and Low-dose Treosulfane for Anti-inflammatory and Angiostatic Treatment in Patients With Hormone-refractory Prostate Cancer

To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for \> 5 ng/ml.

Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved

Progression-free survival, defined as the time from first administration of study drugs to the first PSA value of a PSA non-responder. Responders will be censored with date of PSA response for the analysis. The median time to PSA progression free survival was not achieved

Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. The median time to overall survival rate was not achieved

Health-related quality of life was assessed with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-30) questionnaire and was presented descriptively. The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.

In 15 centers 72 patients were screened, 67 enrolled, of which 65 were treated and 33 completed the treatment phase. Intent to Treat (ITT) population included 61 patients. For the extension follow-up phase 19 patients were included in the safety analysis.

STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)

STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)

STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)

STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane

Age, Continuous

Sex: Female, Male

Study Director

PSA responder - No

PSA responder - Yes

Intent to Treat (ITT) includes the 61 patients treated.

PSA Response Rate

Time to PSA Response

Time to Progression-free Survival

Overall Survival Rate

Baseline: financial difficulties (n=49)

Baseline: appetite loss (n=50)

Baseline: dyspnea (n=49)

Baseline: constipation (n=50)

Baseline: role functioning (n=50)

Baseline: insomnia (n=49)

Baseline: cognitive functioning (n=49)

Baseline: diarrhea (n=50)

Baseline: physical functioning (n=50)

Baseline: pain (n=50)

Baseline: emotional functioning (n=49)

Baseline: social functioning (n=49)

Baseline: fatigue (n=50)

Baseline: global health status (n=49)

Baseline: nausea & vomiting (n=50)

Final Visit: financial difficulties (n=42)

Final Visit: appetite loss (n=43)

Final Visit: dyspnea (n=43)

Final Visit: constipation (n=43)

Final Visit: role functioning (n=43)

Final Visit: insomnia (n=42)

Final Visit: cognitive functioning (n=43)

Final Visit: diarrhea (n=43)

Final Visit: physical functioning (n=43)

Final Visit: pain (n=43)

Final Visit: emotional functioning (n=43)

Final Visit: social functioning (n=43)

Final Visit: fatigue (n=43)

Final Visit: global health status (n=43)

Final Visit: nausea & vomiting (n=43)

Intent to Treat (ITT) includes the 61 patients treated

Quality of Life Assessed With EORTC-30

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer	NCT00427999	Prostate Cancer	imatinib mesyla... Treosulfane etoricoxib pioglitazone dexamethasone	18 Years -	Novartis
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer	NCT00427999	Prostate Cancer	imatinib mesyla... Treosulfane etoricoxib pioglitazone dexamethasone	18 Years -	Novartis

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