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

Original Study ID : CSTI571BDE59

NCT ID : NCT00427999

Brief Title : 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

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.

Source : Novartis

Overall Status : Recruiting

Start Date : February 2007

End Date : August 2009

Completion Date : August 2009

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Enrollment : 70

Verification Date : July 2008

First Received Date : January 25, 2007

Trial 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

Gender : Male

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Status : Recruiting

City : Regensburg

Country : Germany

OutComes

Primary OutComes

Measure : To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane)

Secondary OutComes

Measure : Time to PSA response.

Interventions

Type : Drug

Name : imatinib mesylate

Clinical Trial Name - Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-Refractory Prostate Can