Clinical trial NCT00427999: Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Hormone-refractory
prostate cancer
multitargeted
tyrosinkinase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* Histologically confirmed prostate carcinoma, which has proven progression after primary hormone therapy (surgical or medicinal castration).
* Patients must have increasing PSA levels (within 3 months prior to enrollment) with at least two consecutively increasing PSA levels.
* PSA value before inclusion must be at least 5 ng/ml
* At least 18 years of age.
* At least capable of self care and up of at least 50% of waking hours (ECOG performance status 0 - 2), adequate bone marrow function and lab results.

Exclusion criteria:

* Change of hormone therapy within 6 weeks prior inclusion
* Prior chemotherapy
* Therapy with Imatinib, or therapy with other inhibitors of tyrosinkinase.
* Second neoplasm diagnosed within 5 years before study start.
* Patients who require therapy with warfarin
* Known diagnosis of HIV, hepatitis B, or hepatitis C infection.
* Severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency
* Surgical therapy within 4 weeks before inclusion.
* Prior therapy with isotopes strontium or rhenium.
* Radiation therapy to \> 25% of bone marrow within 4 weeks before inclusion.
* Treatment with other experimental substances within 30 days before study start.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: PSA Response Rate
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Time to PSA Response
timeFrame: every 4 weeks up to 24 weeks
measure: Time to Progression-free Survival
timeFrame: every 4 weeks up to 24 weeks
measure: Overall Survival Rate
timeFrame: every 4 weeks up to 24 weeks
measure: Quality of Life Assessed With EORTC-30
timeFrame: baseline and Final Visit (week 24)
Other outcomes:
Locations:
city: Bad Reichenhall
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Markkleeberg
country: Germany
facility: Novartis Investigative Site
city: Passau
country: Germany
facility: Novartis Investigative Site
city: Planegg
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: