A single stage phase II, multi-centre, open label study of Glivec in combination with pioglitazone, etoricoxib, dexamethasone and low-dose treosulfane for anti-inflammatory and angiostatic treatment in patients with hormone-refractory prostate cancer

• Conditions: prostrate carcinoma; MedDRA version: 14.0Level: LLTClassification code 10036921Term: Prostate carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2006-000218-19-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-09
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Histologically confirmed prostate carcinoma, which has proven progression after androgen deprivation therapy (surgical or medicinal castration).
•Status of hormone refractory prostate cancer (HRPC) according to EAU-guideline.
•Patients must have increasing PSA levels (within 3 months prior to enrollment) with at least two consecutively increasing PSA levels. The first measurement must be above a reference value and has to be assessed at least one week after the reference value. The second confirmatory measurement taken must be greater than the first measurement and has to be assessed at least one week after the first measurement. If however the second confirmatory measurement is not higher than the first measurement then a third confirmatory measurement at least one week after the second measurement must be performed. The patient is eligible if the third confirmatory measurement is higher than the first measurement. The difference between consecutive PSA values must be at least 5% increase.
•PSA value before inclusion (second or third confirmatory measurement) must be at least 5 ng/ml
•At least 18 years of age.
•Serum testosterone levels must be within range of castration (<50ng/dl or < 1.73nmol/l).
•Sufficient bone marrow function: neutrophils ? 2000/µl, hemoglobin ? 10 g/dl, and platelets ? 100x109/l
•ECOG performance status 0 – 2
•Required laboratory results:
a) Liver function: Total bilirubin = 2.,5 times of upper limit of local institution, SGPT, SGOT = 2.,5 x times of upper limit of local laboratory.
b) Renal function: Creatinine = 1.,3 mg/dl.
•Normal cardiac function.
•Life expectancy at least 6 months.
•Written informed consent of the patient prior to screening procedures.
•Patient must be available for scheduled visits.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with bladder cancer or bladder cancer in their medical history
• Macrohematuria of unknown origin
• Patients with risk factors for bladder cancer (such as exposure to aromatic amines or heavy Tobacco smokers); in light of age-related risks, the balanve of benefits and risks shoukd be considered carefully both before initiating and during treatment in the elderly.
•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 (Coumadin®), or phenprocoumon (Marcumar) or any other oral anticoagulant (see Section 6.5.3.).
•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 symptomatic congestive heart failure (NYHA II to IV, see Post-text supplement 6), uncontrolled diabetes, chronic hepatic or renal disease, active uncontrolled infection and chronic inflammatory intestinal disease, auto-immune diseases and angina pectoris
•Inability of performing scheduled visits.
•Surgical therapy within 4 weeks before inclusion.
•Prior therapy with isotopes is not allowed. This includes each radiopharmaceutical li´censed for palliation in prostate cancer or painful osseous metastatic disease, like phosphorus, strontium, rhenium or samarium.
•Radiation therapy to > 25% of bone marrow within 4 weeks before inclusion.
•Controlled filiae in brain.
•Regular blood transfusions.
•Concomitant therapy with other tumor treatment except LHRH agonists.
•Treatment with other experimental substances within 30 days before study start.
•Participation in another clinical trial within 30 days before study start or during the trial.
•Unwilling or unable to comply with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified