This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride work in treating patients with squamous cell lung cancer that is stage IV and has not been treated, or has come back after previous treatment (recurrent). Drugs used in chemotherapy, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nab-paclitaxel and gemcitabine hydrochloride together may be more effective against squamous cell lung cancers than other cancers. Nab-paclitaxel may also help gemcitabine hydrochloride work better.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02525653.
PRIMARY OBJECTIVES:
I. To determine the best objective response (complete response + partial response at any time before progression, by Response Evaluation Criteria in Solid Tumors [RECIST]) of the combination of nab-paclitaxel (albumin-bound paclitaxel) and gemcitabine in patients with stage IV or recurrent squamous cell lung cancer.
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of the combination of albumin-bound paclitaxel and gemcitabine in patients with stage IV squamous cell lung cancers.
II. To estimate 1 year, 2 year, and median progression-free survival (PFS) and overall survival (OS).
III. To explore the correlation between tumor genotype and response.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 120 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: After completion of 4 cycles, patients have the option to receive nab-paclitaxel IV over 120 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorPaul K Paik
