Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT02407600
Eligibility Criteria:
Inclusion Criteria:
* Patient age \> 18 years and able to sign informed consent.
* ECOG PS 0-2
* Patients with stage IV or recurrent NSCLC being treated with carboplatin based regimen with palliative intent.
* Acceptable chemotherapy regimens include:
* Carboplatin (AUC of 5 OR 6) q 21 days with:
* Paclitaxel Q 21 days OR
* Docetaxel Q 21 days OR
* Pemetrexed Q 21 days (non-squamous histology with Vitamin B12 and folate supplementation) OR
* Gemcitabine administered days 1 and 8 Q 21 days OR
* Vinorelbine administered days 1 and 8 Q 21 days
* The addition of bevacizumab to chemotherapy is permitted where indicated and clinically appropriate.
* Patients who have received prior adjuvant chemotherapy for lung cancer ( \> 1 year prior) and have recurred are eligible if it has been \> 1 year since completion of adjuvant chemotherapy.
* Patients who have been treated for locally advanced lung cancer with concurrent chemoradiation but completed such therapy \> 1 year ago are eligible provided they meet all other inclusion criteria.
* Patients who have received prior adjuvant chemotherapy for lung cancer ( \> 1 year prior) and have recurred are eligible if it has been \> 1 year since completion of adjuvant chemotherapy.
* Patients who have been treated for locally advanced lung cancer with concurrent chemoradiation but completed such therapy \> 1 year ago are eligible provided they meet all other inclusion criteria.
* Laboratory parameters:
* Serum creatinine \< 2.0 and
* AST, ALT \< 3 time the upper limit of normal
* Platelet count ≥ 100,00/cumm
* ANC ≥ 1500/ cumm on day of therapy (day # 1 of the cycle)
* Hemoglobin \> 8.0 g/dl
Exclusion Criteria:
* History of allergic reaction to aprepitant or fosaprepitant
* Use of other investigational agents concurrently with chemotherapy
* Uncontrolled systemic hypertension with SBP \> 180 and/ or DBP\> 110
* Concurrent use of pimozide, terfenadine, astemizole, or cisapride (fosaprepitatnt is a dose-dependent inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4). If used concurrently with above agents, there can be elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions. Patients may be enrolled on the study if at least 7 days have elapsed since last dose of such a medication.
* Women who are pregnant or lactating are not eligible. Women of childbearing age musthave a negative pregnancy test within 3 days of treatment and agree to use of contraception during the study period.
* Use of any of the CYP450 inducers like phenytoin, carbamazepine, barbiturates, rifimapicin, rifabutin or St John's wort within 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02407600
Study Brief:
Protocol Section:
NCT02407600