A Study Evaluating the Proton Pump Inhibitor Pantoprazole in Combination With Doxorubicin for Advanced Cancer Patients With an Extension Cohort of Metastatic Breast Cancer Patients
Summary
This is a single-centre, open label, dose finding, phase I study to determine the recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with advanced tumours and no standard treatment options. A minimum of 3 patients will be enrolled per dose level and intra-patient dose escalation is not permitted. Once the RP2D has been identified, six additional patients will be treated at the RP2D to confirm its tolerability. This cohort will include only patients with metastatic breast cancer with no standard treatment options.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Advanced Solid Tumours
Intervention
pantoprazole sodium for injection, doxorubicin hydrochloride injection
Location
Princess Margaret Hospital
Toronto
Ontario
Canada
M5G 2M9
Status
Not yet recruiting
Source
University Health Network, Toronto
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01163903
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:12:10-0400
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Medical and Biotech [MESH] Definitions
Injection Site Reaction
Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.
Hypophysectomy, Chemical
Total or subtotal destruction of the pituitary gland by chemical injection. It is usually achieved by injection of ethyl alcohol via trans-sphenoidal cannulation under stereotaxic control. It is usually performed for the treatment of intractable pain.
Shwartzman Phenomenon
Hemorrhagic necrosis that was first demonstrated in rabbits with a two-step reaction, an initial local (intradermal) or general (intravenous) injection of a priming endotoxin (ENDOTOXINS) followed by a second intravenous endotoxin injection (provoking agent) 24 h later. The acute inflammation damages the small blood vessels. The following intravascular coagulation leads to capillary and venous THROMBOSIS and NECROSIS. Shwartzman phenomenon can also occur in other species with a single injection of a provoking agent, and during infections or pregnancy. Its susceptibility depends on the status of IMMUNE SYSTEM, coagulation, FIBRINOLYSIS, and blood flow.
Flow Injection Analysis
The analysis of a chemical substance by inserting a sample into a carrier stream of reagent using a sample injection valve that propels the sample downstream where mixing occurs in a coiled tube, then passes into a flow-through detector and a recorder or other data handling device.
Kveim Test
Intradermal injection of a heated (pasteurized) saline suspension of sarcoid tissue obtained from a sarcoid spleen or lymph node. In patients with active sarcoidosis a dusky red nodule develops slowly over the next few weeks at the injection site. Histologic examination, an essential part of the complete test, reveals sarcoid tissue.
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