Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajeet Gajra
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; Carboplatin; Fosaprepitant

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.