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Completed

NCT Number: NCT00427999

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bad Reichenhall, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

imatinib mesylate

Drug

Other names: Gleevec, Glivec

Treosulfane

Drug

Other names: Ovastat

Etoricoxib

Drug

Other names: Arcoxia

pioglitazone

Drug

Other names: Actos

Dexamethasone

Drug

Other names: Fortecortin

Primary outcomes

  1. PSA Response Rate

    Time frame: 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 outcomes

  1. Time to PSA Response

    Time frame: 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

  2. Time to Progression-free Survival

    Time frame: 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

  3. Overall Survival Rate

    Time frame: 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

  4. Quality of Life Assessed With EORTC-30

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: INV342

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2007
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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