Hospitalized male and female patients aged ≥ 18 years, suffering of Cystic Fibrosis.

Cystic Fibrosis

Teicoplanin Sandoz administered by inhalation (aerosol).

Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution.

Centro Ricerche Cliniche di Verona - Azienda Ospedaliera Universitaria Integrata di Verona

Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

An Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the sputum of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time points after first inhalation: 0 hours, 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the blood of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time points after first inhalation: 0 hours, 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the urine of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time intervals after first inhalation: 0 hours, 0 - 4 hours, 4 - 12 hours, 12 - 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time intervals will be measured for subsequent inhalations.

Comparison between the concentration (expressed as mg/L) of Teicoplanin measured in the sputum, blood and urine of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg versus additional dosage(s) of Teicoplanin, in case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin.

Measurement of any changes (as %) in the Forced Expiratory Volume in the 1st second (FEV1) measured 30 minutes before and 30 and 60 minutes after a single inhalation of 150 mg of inhaled Teicoplanin. In case of FEV1 reduction > 5% in comparison to baseline the FEV1 will be measured also after 120 minutes from inhalation. In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of any changes (as %) in the blood oxigen saturation measured 30 minutes before and 30 minutes + 4 hours after a single inhalation of 150 mg of inhaled Teicoplanin. In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Evaluation of the number, rate and characteristics of the adverse events occurring to CF patients treated with inhaled Teicoplanin, as recorded in the Case Report Form. Any adverse events occurring during the inhalation visits will be also evaluated from a Tolerability point of view.

Neupharma Srl

Sintesi Research Srl

Aptuit Srl

Pari Pharma GmbH

Centro Ricerche Cliniche di Verona

Prospective, single-arm, exploratory, open-label, dose-escalation study evaluating the pharmacokinetics of inhaled Teicoplanin in Cystic Fibrosis patients.

Paclitaxel 135 mg/m2 over 3 hrs on day 1 Carboplatin IP (AUC= 6.0) on day 1 Paclitaxel 60 mg/m2 IP on Day 8 Repeat q 21 days x 6 cycles
Pelvic 6MV Photon Beam Energy, or IMRT where appropriate 1.8 Gy Dose/FX Total Dose 45 Gy
High Dose Radiation (HDR) x 3, or IMRT where appropriate 5 Gy to 0.5cm Depth from the Vaginal Cylinder Surface Total Dose 15 Gy

Uterine Carcinoma

IV paclitaxel in combination with IP carboplatin

Paclitaxel/Carboplatin

Pelvic radiation therapy

Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin/Taxol Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma

Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

Feasibility will be assessed by: Treatment completion proportion - the proportion of participants who complete the IV paclitaxel/IP carboplatin followed by IP paclitaxel/RT regimen Screening ratio - the number of potential participants screened per enrolled participant

The questionnaires used are EORTC QLQ-C30. QOL will be assessed using the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) version 3.0. To date, more than 2200 studies using QLQ-C30 have been registered. This 30-item summary score captures the dimension of physical well-being, functional well-being, and symptom scales.

Karin Shih

Principal Investigator

Northwell Health

During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.

Gemcitabine doses: 300 mg/m2/week for 6 weeks.

Cervical Cancer

Gemcitabine 300 mg/m2, prepared in 0.5 liters of sodium chloride 0.9%, IV administered in 30 minutes weekly for a maximum of 6 weeks.
Radiotherapy will start the first week, or as soon as the blood count is normal or the patient has recovered after blood transfusion. Radiotherapy will be applied, using an external beam releasing 40-50.4 Gy in 20-28 fractions: 1.8 Gy/day for 5 days/week, during 4 to 6 weeks.
Intracavitary brachytherapy will be added to reach a total EQD2 dosage (α/β=10) of 78-86 Gy.

Gemcitabine

National Institute of Cancer

Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

A Phase II Clinical Trial to Evaluate the Potential of Concomitant Chemoradiotherapy With Gemcitabine in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

Safety of gemcitabine regarding renal function will be assessed through glomerular filtration rate.
An improvement of 10 ml/min/1.73m2 as compared to basal glomerular rate is expected by the end of treatment.

Toxicity will be evaluated according to the toxicity criteria of CTCEA v. 4.03. A toxicity index of <4 is expected during treatment.

Dr. Lucely Cetina Pérez

MD, Master of Science

National Institute of Cancerología

Instituto Nacional de Cardiologia Ignacio Chavez

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Phase II open, single arm, national, non-randomized clinical trial; to evaluate safety of gemcitabine in patients with locally advanced cervical cancer and renal dysfunction, referring to the INCAN.

325mg ASA OD during course of chemotherapy

Hearing Loss

Ototoxicity

325mg ASA OD for the duration of the cisplatin

ototoxicity/albumine

Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

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