ABC-02 regime - gemcitabine and cisplatin with a shortened hydration time and administration of a newer antiemetic

ABC-02 regime - gemcitabine and cisplatin with currently approved hydration time and administration of the current choice of antiemetic

Gallbladder Cancer

Hydration is reduced to 1 hour and 40 minutes and Akynzeo is administered as an oral drug instead of Ondansetron being given as an IV before chemotherapy.

Shortened hydration time and dispensary of Akynzeo

Hydration remains at around 6 hours and 30 minutes due to no oral fluids being consumed prior to treatment and normal saline being administered for 90 minutes before cisplatin and then for 2 hours after cisplatin and before gemcitabine administration

Standard of care

Imperial College Healthcare NHS Trust

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

A Prospective Study of Tolerance Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

To compare the proportion of patients who experience CTCAE V3.0 grade 3 or 4 nausea (using a shortened hydration protocol and a modern antiemetic regimen) with those who are in the ABC02 trial arm which used a longer hydration procedure and a standard antiemetic regimen

To compare proportion of patients who experience CTCAE V3.0 grade 3 or 4 impaired renal function

To compare proportion of patients who have a complete response i.e. no nausea and vomiting recorded as a toxicity

To compare the proportion of patients who experience renal dysfunction (a deterioration of calculated GFR of below 60)

To determine the incidence of early and delayed chemotherapy induced emesis using the MAT antiemesis tool

To determine the incidence of nocturia in the first night after chemotherapy

Measuring the length of hospital visit (time in to time out) for each patient per treatment visit and comparing the difference between arms

Chugai Pharma UK Limited

This is a single arm, open-label study of SGI-110 in patients with MPN. SGI-110 will be administered subcutaneously at a dose of 60 mg/m2 on days 1-5, repeated every 28 days. Toxicity will be evaluated using the NCI Common Terminology Criteria for Adverse Events Active Version 4. The frequency of toxicities per organ system will be tabulated using descriptive statistics. All patients who receive any amount of the study drug will be evaluable for toxicity

Myeloproliferative Neoplasms

SGI-110

Weill Cornell Medical College

A Phase II Study of SGI-110 in Philadelphia-Negative Myeloproliferative Neoplasms

Complete remission rate is defined as number of subjects with complete remission according to the international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults.

Hematological response is defined as number of subjects with hematological response according to the international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults.

Spleen response rate is defined as improvement in size of spleen as measured by US/CT scan and according to the international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults.

Symptom improvement response is defined as number of subjects with improvement in symptoms response as defined by Myelofibrosis Symptom Assessment Form (MF-SAF)

Weill Medical College of Cornell University

Astex Pharmaceuticals, Inc.

Breast Cancer

Bone Metastasis

Pain

chemoradiation

Rabin Medical Center, Beilinson Campus

Chemoradiation for Bone Metastasis

Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis

Patients were asked to score their pain on a scale of 0 (no pain) to 10 (worst possible pain) before treatment and at 1, 2, 4, 8 and 12 weeks after treatment initiation.

Consumption of analgesics was evaluated by the physician using the 5-point WHO score, as follows: level 0, no analgesics required; level 1, non-narcotic analgesics required occasionally; level 2, non-narcotic analgesics required regularly; level 3, narcotic analgesics required occasionally; level 4, narcotic analgesics required regularly

cytidine/nelabums

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

A Phase II Study of SGI-110 in Philadelphia-Negative Myeloproliferative Neoplasms

Chemoradiation for Bone Metastasis

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