A Phase II Study of Albumin-Bound Paclitaxel and Gemcitabine in Patients with Stage IV Squamous Cell Lung Cancer

Full Title

A Phase II Trial of Albumin-Bound Paclitaxel and Gemcitabine in Patients with Untreated Stage IV Squamous Cell Lung Cancers

Purpose

Chemotherapy for lung cancer often includes a platinum-containing drug as well as another anticancer medicine. Studies have suggested that chemotherapy with albumin-bound paclitaxel and gemcitabine might be more effective for squamous cell lung cancers than other types of lung cancer. Albumin-bound paclitaxel increases the effectiveness of gemcitabine against certain cancers. This two-drug combination is now used to treat pancreatic cancer.

In this study, researchers want to evaluate the safety and effectiveness of albumin-bound paclitaxel and gemcitabine in people with stage IV squamous cell lung cancers. Each of these drugs is already used to treat lung cancer, but their use in combination for lung cancer is considered investigational. Both drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IV squamous cell lung cancer.
  • Patients may not have had treatment for metastatic disease, but may have had prior treatment before or after lung cancer surgery for an earlier stage of disease. For those patients, at least 6 months must pass between completion of prior chemotherapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study or to inquire about eligibility, please contact Dr. Paul K. Paik at 646-888-4202.

Protocol

15-054

Phase

II

Investigator

Co-Investigators

Locations