Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell lung cancer (NSCLC)


Clinical Trial Description

This will be a non-randomized phase II study evaluating the safety and efficacy of weekly nab-paclitaxel for second-line treatment in 42 elderly patients, who are 70 years of age or greater with non-small cell lung cancer (NSLC). Patients will be required to have progressed on a single prior regimen. Nab-paclitaxel 100mg/m2 will be administered intravenously, weekly for 3 weeks of every 4-week cycle. After every two cycles of therapy, imaging will be performed to assess for response. Patients will be eligible to continue receiving therapy until the time of disease progression.

Primary Objectives To evaluate the tolerability of weekly nab-paclitaxel in older adults with advanced lung cancer who have progressed on at least 1 prior regimen after 6 cycles or 3 weeks after discontinuation of treatment, for those who come off treatment earlier.

Secondary Objectives To estimate overall survival To estimate progression-free survival To estimate the response rate

Correlative Objectives To explore baseline components of the Geriatric Assessment (GA) as predictors of chemotherapy tolerance and overall survival To explore the use of p16 measurements in the elderly as predictors of chemotherapy tolerance and overall survival To explore the impact of weekly nab-paclitaxel treatment on quality of life, as measured by Lung Cancer Symptom Scale (LCSS) and Functional Assessment of Cancer Therapy-Lung (FACT-L). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01702844
Study type Interventional
Source UNC Lineberger Comprehensive Cancer Center
Contact
Status Completed
Phase Phase 2
Start date June 25, 2013
Completion date July 12, 2019

See also
  Status Clinical Trial Phase
Completed NCT01204099 - Study of PX-866 and Docetaxel in Solid Tumors Phase 1/Phase 2
Recruiting NCT04083599 - GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors Phase 1/Phase 2
Completed NCT00148798 - Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) Phase 3
Recruiting NCT06026410 - KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors Phase 1
Completed NCT02988817 - Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT01005797 - Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung Cancers Phase 1
Recruiting NCT00637910 - Tarceva Italian Lung Optimization tRial Phase 3
Active, not recruiting NCT03447678 - Pembrolizumab in First Line Treatment of Advanced NSCLC Patients With PD-L1 Low Tumors. Phase 2
Completed NCT02456246 - Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT N/A
Terminated NCT01741155 - Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC) Phase 2
Completed NCT02014324 - Single Scope Staging of Lung Cancer With Endosonography N/A
Completed NCT01594398 - Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer Phase 1
Completed NCT01323062 - Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects Phase 1
Active, not recruiting NCT04772989 - A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies Phase 1
Completed NCT00492206 - Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC Phase 2
Completed NCT00820417 - Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib Phase 1
Completed NCT02639026 - Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers Phase 1
Completed NCT01282437 - Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC Phase 3
Active, not recruiting NCT04721015 - Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors Phase 1
Not yet recruiting NCT05473156 - A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies Phase 1/Phase 2