At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
Nab-paclitaxel +1 moredrug
Likely dose
Nab-paclitaxel 100 mg/m² on days 1 and 8 of a 21-day cycle; Gemcitabine 1000 mg/m² on days 1 and 8 of a 21-day cycleAI-extracted
Key inclusion· 5
- ✓Histologically or cytologically confirmed SCLC or small cell cancer from other organs or poorly differentiated neuroendocrine tumors treated as SCLC, with metastatic or recurrent disease
- ✓ECOG performance status 0-2
- ✓At least one measurable lesion per RECIST 1.1
- ✓Progression during or after first-line chemotherapy. Prior maintenance therapy, targeted therapy, immunotherapy, or Rovalpituzumab allowed. Chemo-radiation eligible if progression within 1 year.
Key exclusion· 8
- ✕Prior treatment with taxane (docetaxel or paclitaxel) for small cell lung cancer
- ✕Allergy or hypersensitivity to albumin-bound paclitaxel or gemcitabine
- ✕Symptomatic untreated CNS metastasis or treated brain metastasis not stable for 4 weeks or requiring steroids
- ✕Myocardial infarction, unstable angina, bypass graft, NYHA Class III-IV heart failure, uncontrolled hypertension, significant cardiac dysrhythmia/ECG abnormality, stroke, TIA, or seizure within prior 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer or Those With Progression on First Line Therapy
In Brief
A Phase 2 clinical trial evaluating Nab-paclitaxel and Gemcitabine for Small Cell Lung Cancer (SCLC). Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer (SCLC)
CountriesUnited States
CollaboratorsCelgene Corporation
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartAug 2016
Primary CompletionSep 2021
Study CompletionJul 2022
TodayJul 2026
First PostedMay 12, 2016
Enrollment StartAug 29, 2016
Primary CompletionSep 23, 2021
Study CompletionJul 7, 2022
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.1 years ago
Interventions
Nab-paclitaxeldrug
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle
Gemcitabinedrug
Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle