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STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

imatinib mesylate

Treosulfane

etoricoxib

pioglitazone

dexamethasone

Novartis Pharmaceuticals

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.

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

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

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.

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

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

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

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.

In 15 centers 72 patients were screened, 67 enrolled, of which 65 were treated and 33 completed the treatment phase. Intent to Treat (ITT) population included 61 patients. For the extension follow-up phase 19 patients were included in the safety analysis.

STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)

STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)

STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)

STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane

Age, Continuous

Sex: Female, Male

Study Director

PSA responder - No

PSA responder - Yes

Intent to Treat (ITT) includes the 61 patients treated.

PSA Response Rate

Time to PSA Response

Time to Progression-free Survival

Overall Survival Rate

Baseline: financial difficulties (n=49)

Baseline: appetite loss (n=50)

Baseline: dyspnea (n=49)

Baseline: constipation (n=50)

Baseline: role functioning (n=50)

Baseline: insomnia (n=49)

Baseline: cognitive functioning (n=49)

Baseline: diarrhea (n=50)

Baseline: physical functioning (n=50)

Baseline: pain (n=50)

Baseline: emotional functioning (n=49)

Baseline: social functioning (n=49)

Baseline: fatigue (n=50)

Baseline: global health status (n=49)

Baseline: nausea & vomiting (n=50)

Final Visit: financial difficulties (n=42)

Final Visit: appetite loss (n=43)

Final Visit: dyspnea (n=43)

Final Visit: constipation (n=43)

Final Visit: role functioning (n=43)

Final Visit: insomnia (n=42)

Final Visit: cognitive functioning (n=43)

Final Visit: diarrhea (n=43)

Final Visit: physical functioning (n=43)

Final Visit: pain (n=43)

Final Visit: emotional functioning (n=43)

Final Visit: social functioning (n=43)

Final Visit: fatigue (n=43)

Final Visit: global health status (n=43)

Final Visit: nausea & vomiting (n=43)

Intent to Treat (ITT) includes the 61 patients treated

Quality of Life Assessed With EORTC-30

Overall Study

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Syndrome

Breast Neoplasms

Peripheral Nervous System Diseases

Pain

Acute Pain

Somatoform Disorders

Mental Disorders

Psychotic Disorders

Neurologic Manifestations

Acute Graft Versus Host Disease

Docetaxel

Taxane

Prophylactic etoricoxib (60 mg) was administered orally at each course of docetaxel-containing chemotherapy, which started from the day of chemotherapy and was performed once per day for 8 days (day 1-8).

Kun Wang, MD

A phase II randomized clinical trial was conducted to determine whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Docetaxel plays a key role in reducing the recurrence of early-stage breast cancer as well as improving survival outcomes of advanced breast cancer patients, but it causes a variety of adverse events, including myalgia and arthralgia, peripheral neuropathy, febrile neutropenia, and hypersensitivity reactions and so on. The myalgia and arthralgia induced by docetaxel, which have been together referred to as taxane-associated acute pain syndrome (T-APS), were reported to occur in 3.6% to 70% of patients, and the symptoms usually occurred 24-48 hours after docetaxel infusion and lasted for 3-5 days. Previous studies found that patients who experienced myalgia and arthralgia due to docetaxel administration were more likely to have chronic peripheral neuropathy, which supported that T-APS could be a form of neurologic toxicity. T-APS may significantly influence patients' sleep and daily life, and even caused discontinuation of chemotherapy. Therefore, it is clinically meaningful to explore some prophylactic drugs for the T-APS. Previous studies had used glutamine, corticosteroids, Shakuyaku-Kanzo-To (a Japanese herb), and gabapentin to prevent paclitaxel-induced myalgia and arthralgia, but failed to provide enough evidence for clinical practice. Etoricoxib, a selective COX-2 inhibitor, is a nonsteroidal anti-inflammatory drug (NSAID) that has showed comparable efficacy in acute and chronic pain, with fewer gastrointestinal (GI) adverse events compared with traditional NSAIDs. Therefore, we conducted a phase II randomized clinical trial to investigate whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.

Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib

Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib for Breast Cancer Patients: A Phase II Randomized Trial

Total incidence of myalgia and arthralgia of patients across all cycles of docetaxel chemotherapy

Incidence of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy

Severity of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy; the severity of pain was evaluated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).

Duration of myalgia and arthralgia of patients at each cycle of docetaxel chemotherapy; the duration of pain was counted by days.

incidence of severe myalgia and arthralgia (score, defined as greater than 5 on a scale from 0 to 10) of patients during the period of docetaxel chemotherapy by cycle and across all cycles

Functional Assessment of Cancer Therapy-Breast（FACT-B）subscale during the period of docetaxel chemotherapy was assessed; the scores range from 0 to 144, higher scores mean a better outcome (higher quality of life)

Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale (FACT-Ntx score \<44), Eastern Cooperative Oncology Group neuropathy scale (ENS) subscale and EMG were performed at 3 months after the completion of chemotherapy.

Assessment of adverse events was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale.

Guangdong Provincial People's Hospital

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer	NCT00427999	Prostate Cancer	imatinib mesyla... Treosulfane etoricoxib pioglitazone dexamethasone	18 Years -	Novartis
Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib	NCT04565600	Pain Syndrome	Etoricoxib	18 Years -	Guangdong Provincial People's Hospital
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer	NCT00427999	Prostate Cancer	imatinib mesyla... Treosulfane etoricoxib pioglitazone dexamethasone	18 Years -	Novartis

Spots Global Cancer Trial Database for etoricoxib

Every month we try and update this database with for etoricoxib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for etoricoxib

Every month we try and update this database with for etoricoxib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for etoricoxib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.