NCT02769832

Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer

Phase II Study of Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer or Those With Progression on First Line Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Muhammad Furqan · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if Abraxane and Gemcitabine given together will be effective in treating small cell cancer that has progressed after one line of treatment.

Detailed description

This study is designed as a second-line therapy for patients with histologically or cytologically confirmed small cell lung cancer or small cell cancer from other organs or poorly differentiated neuroendocrine tumors that are treated like small cell cancer. This study is for patients with metastatic or recurrent disease. Eligible patients will receive Nab-Paclitaxel (Abraxane), 100 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle followed by Gemcitabine, 1000 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle. Participants can continue receiving Nab-Paclitaxel and Gemcitabine until disease progression, unacceptable toxicity or withdrawal from the study. Tumor measurements will be done every 2 cycles.

Conditions

• Small Cell Lung Cancer (SCLC)

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel	Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle

Timeline

• Start date: 2016-08-29
• Primary completion: 2021-09-23
• Completion: 2022-07-07
• First posted: 2016-05-12
• Last updated: 2025-07-29
• Results posted: 2023-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study