Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment

Primary Outcome Measures

• • Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures

• • • Overall survival time [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Eligibility

Criteria

Inclusion Criteria

Histologically or cytologically proven diagnosis of malignant mesothelioma

Man or woman 21 years and above

Adequate performance status (ECOG 0, 1, or 2)

Patient must have adequate organ function as the following:

1. Absolute neutrophils counts (ANS) > 2500/μL.
2. Platelets > 150,000/μL.
3. Hemoglobin > 10 g/dL.
4. Total Bilirubin < 1.5 Upper Normal Limit (UNL).
5. Alanine aminotransferase (ALT), AST (aspartate aminotransferase)and alkaline phosphatase must be <
6. 1.5 times of the upper limit of normal.
7. LDH (lactate dehydrogenase) < 500 int. unit/L
8. Estimated GFR (glomerular filtration rate) > 45 ml/min.

Written informed consent

Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.

Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion Criteria

Evidence of liver metastasis

Any bone involvement

Prior radiotherapy, cytotoxic or biologic systemic treatment

Any history of Asthma or COPD (chronic obstructive pulmonary disease) that needs systemic therapy with steroids for more than 2 weeks during the last 2 years.

Treatment with systemic steroids for more then 1 month during the last year.

Active smokers that are unable to quit smoking

Any treatment with investigational agent within 30 days prior to registration for protocol therapy.

Cerebrovascular accident, transient ischemic attack or myocardial infarction within 6 months prior to registration for protocol therapy.

Evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.

Any history of solid or hematologic malignancies.

Patient with positive HIV serology at screening.

Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.

Uncontrolled hypertension (greater than 150/100 mm Hg despite optimal medical therapy).

Evidence of ongoing cardiac dysrhythmias of NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 grade 2.

Patients in whom radiation or surgery is indicated

Significant swallowing disorders.

Small bowel surgery.

Suspicion of absorption disruption as a result of abdominal radiation

Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.

Evidence of concurrent (less than 5 years) second malignancy

Mental disorders.

Inability to give written informed consent.