Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Brain Neoplasms

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Hypoglycemic Agents

Anti-Infective Agents

Antineoplastic Agents

Lipid Regulating Agents

Herbal and Botanical

Ibuprofen

Metformin

Doxycycline

Mebendazole

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Anthelmintics

Tubulin Modulators

Antimitotic Agents

Cola

Subjects will take the following treatments and have their data collected from their medical records every 3 months.

* Oral atorvastatin up to 80mg uid, for study duration.
* Oral metformin up to 1000mg uid, increased to bid if tolerated after 2 weeks, for study duration.
* Oral doxycycline 100mg uid, for study duration.
* Oral Mebendazole 100mg uid, for study duration.

While subjects are being treated with the four metabolic drugs, every 3 months they will bring in their medical records and data will be collected to determine the effect of the intervention

Metabolic treatment

Samir Agrawal, MRCP FRCPath

The purpose of this study is to determine the effectiveness of a regimen of selected metabolic treatments for patients with cancer in a real world setting and to conduct exploratory analysis on the relationship between the degree of response and changes in biochemical markers (such as glucose and lipid levels).

\*This study has been designed to collect data prospectively and to retrospectively analyse data on the metabolic treatments within the cancer clinic. The retrospective study is ongoing, while the prospective study has not yet started.\*

This is a real world study since this gives the best opportunity to properly examine the effect of multi-drug regimens in representative populations. Including a standard of care arm is inappropriate, in a population in which that standard of care has already been shown to be ineffective or intolerable.

Patients will be sent to the study clinic directly by their Health Care Professionals ("HCP's") .

The study will consist of a pre-screening visit to determine eligibility for inclusion into the study, an initiation visit and then a follow up visit every three months thereafter. If required, unscheduled visits may take place. Day 0 (baseline) for each patient will be the initiation visit when study treatment is started.

Prior to conducting any study-related procedures, subjects will provide written informed consent, eligibility will be assessed, a medical history and past medical records will be taken and vital signs will be measured. These records will include the stage of their disease, response to previous cancer therapy, their prior and current medications and any specific regimen they are currently on for their cancer. If prior medical records do not contain sufficient information to determine a baseline for the patient, additional blood tests and scans will be undertaken as appropriate.

Patients will be monitored quarterly thereafter when blood tests (e.g. safety parameters, glucose, cholesterol, immune response and cancer markers where applicable) and scans (where applicable) will be taken.

All patients will be on the same drug regimen (see below) at the same doses throughout the study. All patients will be followed up until they choose to leave the study, or death.

Data from all patients recruited to the study will be analysed using an Intention-to-treat (ITT) philosophy, so data will be included in the primary analysis irrespective of whether the dose regimen was followed throughout the study. If appropriate, and numbers allow, analysis will also be conducted on the Per Protocol population, comprising those patients who adhere to the regimen as prescribed.

Survival analysis methods will be used to estimate the Overall survival associated with the study regimen for each type of cancer. These estimates will be interpreted in the light of data obtained from the literature, and from eliciting expert opinion. Bayesian methods may be used where appropriate.

Tumour response, where applicable, will be summarised in tables and graphs. Estimates of response rates will be presented for each cancer type with confidence intervals.

The relationship between changes in biochemistry values (glucose, lipids) and efficacy outcomes (Progression Free Survival (PFS), Overall Survival (OS) and HRQoL) will be investigated graphically, or using other methods as appropriate.

Further exploratory analysis to investigate the effects of other factors such as age , ethnic backgrounds , cancer stage, and response to prior therapy, will also be conducted in order to try and characterise the profile of patients most likely to benefit from the study regimen.

The characteristics of patients on the regimen and those who do not stay on the regimen, for whatever reason, will be summarised to see whether there is any observed bias. If appropriate, methods will be used to adjust for any observed bias, for example using propensity scores. OS can then be assessed adjusted for this to try and mitigate for any possible risk of bias which can occur in uncontrolled studies. Furthermore, by enrolling all eligible patients over a specified time frame, it is hoped that the risk of bias should be further reduced. In addition, a large number of patients are expected to participate in the study.

Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer

A Non Randomised, Non Blinded Real World Trial of the Safety, Tolerability and Effectiveness of Metabolic Medicines for the Treatment of Cancer Compared Against Matched Controls

Adverse events reported by the subject or their HCP.

• Quarterly assessment of routine laboratory tests

Overall survival for all cancer types and for each cancer type (years and months)

Tumour size for all cancer types and for each cancer type. Units of size vary depending on cancer type.

Tumour spread (metastasized) to other tissues/organs, for all cancer types and for each cancer type. This is measured as either 0 for no spread or 1 for confirmed spread.

Tumour number for all cancer types and for each cancer type

Cancer biomarkers for all cancer types and for each cancer type. Units of measurement vary depending on the cancer type. When biomarkers, either alone or in combination with other biomarkers, are raised above normal they are seen as predictive of cancer of progression. If returned to normal are indicative of treatment response.

Health Clinics Limited

Symptoms and General Pathology

Prostatic Neoplasms

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Docetaxel

Prednisone

Lenograstim

Taxane

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Adjuvants, Immunologic

Immunologic Factors

Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy.

Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Cabazitaxel

Prednisone 10 mg on Day 1 of the first cycle and continue taking 10 mg po daily for the entire cycle.

Granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia.

Granulocyte colony-stimulating factor (G-CSF)

Dale Shepard, Md, PhD

Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and older) with advanced prostate cancer who have progressed during or after treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous (through a vein) infusion plus prednisone by mouth twice daily, and following the chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF). G-CSF will help the body produce more white blood cells, which should help decrease the risk of getting an infection while being treated with cabazitaxel.

This is a single arm, open label, phase II trial of cabazitaxel every 3 weeks in patients who are ≥ 75 years of age with castration-resistant, metastatic prostate cancer who have progressed during or after docetaxel.

Primary objective:

-The primary objective is to determine the efficacy of cabazitaxel in men 75 years of age or older with castration-resistant, metastatic prostate cancer who have progressed during of following treatment with docetaxel.

Secondary objectives:

* To characterize the safety and tolerability of cabazitaxel in patients ≥ 75 years of age
* To determine the PSA response
* To determine the effect of cabazitaxel on functional status using geriatric assessments

Exploratory objectives:

* Determine the effect of therapy with cabazitaxel on the number of circulating tumor cells (CTC)
* To measure the effects of cabazitaxel on apoptosis in CTCs from patients ≥ 75 years of age using H2AX and M30 as biomarkers.
* To determine the relationship between geriatric-focused assessment of comorbidity and functional ability and toxicity and response.

Patients will receive cabazitaxel 25 mg/m2 every 3 weeks with 10 mg prednisone daily until progression, intolerance of therapy, or withdrawal of consent. Patients will receive granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia. Patients will be followed for 28 days after discontinuation of therapy or death, whichever occurs first. Patients with serious adverse events at the time of removal from the trial will be followed until the toxicities resolve or are deemed irreversible by the treating physician.

Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer

Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel

Number of CTC at baseline and after treatment with cabazitaxel

Level H2AX and M30 in CTCs at baseline and after treatment with cabazitaxel

Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy. Progression-free survival defined as PSA progression, tumor progression in patients with measurable disease, or death.

The assessment of safety will be based on the frequency and severity of adverse events. The incidence of treatment-emergent adverse events will be summarized by organ system, severity based on CTCAE (Common Terminology Criteria for Adverse Events) version 4.02, and relation to study drug by dose cohort. Adverse events assessed after each treatment cycle.

PSA response defined as a 50% or more reduction in serum PSA concentration in patients with a serum PSA concentration of 20 μg/L or more at baseline and confirmed with a repeat PSA measurement after at least 3 weeks.

Geriatric assessment to determine the relationship between functional ability or comorbidity and treatment response or toxicity. Patients will be have a geriatric assessment which will included a range of assessments, such as the Mini Mental Status Exam, Get Up and Go test, and the Geriatric Depression Scale, at baseline and after every 2 cycles of therapy.

Case Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Head and Neck Neoplasms

Lung Neoplasms

Urinary Bladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

IV 150 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Picoplatin

Robert Earhart, MD, PhD

The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm.

Phase 1 and 2 studies have demonstrated that picoplatin, a next-generation platinum analogue designed to avoid drug resistance, has activity when administered IV in a variety of cancers. Preclinical and clinical studies indicate that picoplatin may be effective in platinum refractory or resistant cancer.

Preclinical data in beagle dogs have shown that picoplatin had no effect on cardiovascular function, including the QT interval. In the cumulative human trial experience, the cardiovascular serious adverse events that have occurred are consistent with events expected in patients with advanced malignant disease and do not suggest any propensity toward drug-related serious ventricular arrhythmias or sudden death.

The purpose of this trial is to conduct a formal study to specifically evaluate the effect of picoplatin on the QT/QTc interval as measured by the ECG, and to correlate QTcF interval with plasma total and ultrafilterable platinum concentrations. This study is also being conducted to ensure the safety of picoplatin with regard to the QT/QTc interval. Patients who choose to participate in this study will also be given the opportunity to continue to receive picoplatin until limited by toxicity or disease progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited
Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer	NCT01750866	Castrate-resist...	Cabazitaxel Prednisone Granulocyte col...	75 Years -	Case Comprehensive Cancer Center
Cardiac Safety Assessment Study of Picoplatin in Solid Tumors	NCT00710697	Solid Tumors	Picoplatin	18 Years -	Poniard Pharmaceuticals
Cardiac Safety Assessment Study of Picoplatin in Solid Tumors	NCT00710697	Solid Tumors	Picoplatin	18 Years -	Poniard Pharmaceuticals
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited

Spots Global Cancer Trial Database for prostrate cancer