Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Carcinoma, Non-Small-Cell Lung, Docetaxel
Brief summary
The study will be a prospective open-label single-center study in previously treated patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated. Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R. CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3 Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be considered or subsequent therapy.
Interventions
Anti cancer agents
DRUGDocetaxel
Chemotheraphy
Sponsors
Oshadi Drug Administration
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Locally advanced or metastatic NSCLC (IIIB-IV) * Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy * Man or woman 21 years and above * Adequate performance status (ECOG 0, and 1) * Patient must have adequate organ function * 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
* Any treatment with investigational agent within 10 days prior to registration for protocol therapy. * Cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months prior to registration for protocol therapy. * Evidence of pulmonary embolism within 3 months prior to registration for protocol therapy. * Any history of hematologic malignancies. * Patient with known 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 (\>160/100 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 mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption. * Evidence of concurrent (\< 5 years) second malignancy * Mental disorders. * Inability to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival time | 12 months | overall survival of the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and serious adverse events occurence | One month following treatment initiation | Adverse events and serious adverse events occurred during the study |
| Patient report outcome | 12 months | To assess patients quality of life by QLC30 questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 12 months | time from treatment initiation to documentation of disease progression or death) |
| Duration of Response (DoR); | 12 months | response duration to the drug |
| Change in tumor size | 12 weeks | changes in tumor size |
Countries
Israel
Contacts
Primary ContactHanna Levy, Dr.
Outcome results
None listed