• Pemetrexed and cisplatin will be admixed together in 1 liter of normal saline. The admixture of pemetrexed/cisplatin is stable for 4 hours and should be prepared and delivered immediately before use in the OR. The length of the pemetrexed/cisplatin lavage will be 1 hour.

Mesothelioma

Pemetrexed

Cisplatin

Baylor St Lukes

Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas

Phase I Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas

Shawn Groth

Assistant Professor

Baylor College of Medicine

Intervention: Probiotic formula PROBIO-FIX INUM® will be administered at a dose of 3x1 cps per day orally for 6 weeks. No premedication or patient monitoring after administration of probiotic formula is required. Probiotic formula may be taken after meals or snacks to reduce stomach upset. Swallow the capsule or in case of problems with swallowing, capsule can be opened, content mixed with small amount of food. Food must not be hot.
Patients should receive full supportive care during the study, including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoetin, or bisphosphonates, when appropriate.

Intervention: Maltodextrin will be used for placebo group and will be administered at a the same dose as active formula (3x1 cps per day orally for 6 weeks).
Patients should receive full supportive care during the study, including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoetin, or bisphosphonates, when appropriate.

Diarrhea

Cancer

Each capsule contents: 2 lyophilized probiotic strains, total amount of minimum 7x10 9 CFU/cps, ratio LGG®: BB-12® = 50% : 50% (Culture percentages are based on cell concentration and are approximate) Lactobacillus rhamnosus GG® (ATCC 53103) Bifidobacterium animalis subsp. lactis BB-12® (DSM 15954) Additives: maltodextrin, microcrystalline cellulose, silicium dioxide, magnesium stearate

PROBIO-FIX INUM®

Placebo

National Cancer Institute

Prevention of Irinotecan Induced Diarrhea by Probiotics

Prevention of Irinotecan Induced Diarrhea by Probiotics: A Phase III Study

To determine the efficacy (as measured by prevention of grade 3/4 diarrhea) of probiotic formula PROBIO-FIX INUM® given orally to patients with colorectal cancer starting new line of irinotecan based chemotherapy. Response will be defined as prevention of grade 3/4 diarrhea according to definition of NCI CTC version 4.0

Progression-free survival period will be evaluated according to standard protocol.

To determine the efficacy (as measured by prevention of grade 1/2 diarrhea) of probiotic formula PROBIO-FIX INUM® given orally to patients with colorectal cancer during first 6 weeks of irinotecan based chemotherapy. Response will be defined as prevention of grade 1/2 diarrhea according to definition of NCI CTC version 4.0

To determine the efficacy (as measured by prevention of enterocolitis) of probiotic formula PROBIO-FIX INUM® given orally to patients with colorectal cancer starting new line of irinotecan based chemotherapy. Response will be defined as prevention of enterocolitis during first 6 weeks of irinotecan based chemotherapy according to definition of NCI CTC version 4.0.

Safety and toxicity will be evaluated according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) (see Appendix D; http://www.fda.gov/cder/cancer/toxicityframe.htm).

S&D Pharma SK s.r.o.

National Cancer Institute, Slovakia

Dronabinol 2.5 mg will be taken orally with water twice per day for two days.

Dronabinol 5 mg will be taken orally with water twice per day for two days.

Placebo will be taken orally with water twice per day for two days.

Dronabinol 2.5 mg Bid

Dronabinol 5 mg Bid

Total

Sex: Female, Male

Region of Enrollment

Body Mass Index (BMI)

The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.

Colonic Transit Geometric Center

The time for half of the ingested solids or liquids to leave the stomach.

Gastric Emptying Half-Time (t1/2)

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Colonic Filling at 6 Hours

Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.

Ascending Colon Emptying T 1/2

Proportion of stomach contents emptied at a 2 and 4 hours.

Gastric Emptying at 2 and 4 Hours

Colonic Transit Geometric Center at 24 Hours

Overall Study

Dr. Michael Camilleri

Irritable Bowel Syndrome

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects will receive either 2.5 mg bid, or 5 mg bid, taken orally with water for 2 days.

Dronabinol

Placebo will match study drug; taken orally with water twice per day for two days.

charcoal/diare

Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas

Prevention of Irinotecan Induced Diarrhea by Probiotics

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

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