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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: imatinib mesylate; Drug: Treosulfane; Drug: etoricoxib; Drug: pioglitazone; Drug: dexamethasone

• Registration Number: NCT00427999
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-29
• Study Start: 2007-02
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Results First Submitted: 2016-08-10
• Results First Submitted QC: 2016-08-10
• Status Verified: 2016-10
• Results First Posted: 2016-10-06
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane	imatinib mesylate	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane	Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane	pioglitazone	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane	etoricoxib	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane	dexamethasone	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
PSA Response Rate	up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival Rate	every 4 weeks up to 24 weeks	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
Quality of Life Assessed With EORTC-30	baseline and Final Visit (week 24)	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.
Time to PSA Response	every 4 weeks up to 24 weeks	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
Time to Progression-free Survival	every 4 weeks up to 24 weeks	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Tübingen, Germany