Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Non-small Cell Lung Cancer, Vomiting, Nausea, Emesis
In brief
This study evaluates the addition of fosaprepitant to currently available antiemtic treatments of carboplatin chemotherapy-induced nausea and vomiting in advanced non-small cell lung cancer patients. Half of the patients will receive fosaprepitant in their first chemotherapy cycle, and a placebo on their second chemotherapy cycle. The other half of the patients will begin their first chemotherapy cycle.
Key facts
- Study ID
- NCT02407600
- Run by
- Ajeet Gajra
- People needed
- 150
- Starts
- 2015-04-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2015-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- SUNY Upstate Medical University — Syracuse, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.