Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02590003|
Recruitment Status : Terminated (Trial was stopped after non-response to treatment.)
First Posted : October 28, 2015
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-small Cell Lung||Drug: Carboplatin Drug: Nab-paclitaxel||Phase 2|
The primary objective of this trial is to compare the treatment failure-free survival rate in high-risk elderly patients, identified by geriatric assessment, treated with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel in advanced non-small cell lung cancer. Treatment failure-free survival is the most appropriate primary outcome as it captures excessive toxicity due to chemotherapy in addition to death and disease progression.
The secondary objectives are to evaluate grade 3-5 toxicities, overall response rate, progression free survival, symptom assessment, and overall survival between the two randomization arms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Combination Versus Single Agent Chemotherapy in High-risk Elderly Patients With Advanced Non-small Cell Lung Cancer|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Platinum-based doublet chemotherapy
Active Comparator: Single agent chemotherapy
-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle
- Treatment Failure-free Survival [ Time Frame: 90 days ]
- Overall Response Rate [ Time Frame: start of treatment to disease progression/recurrence, up to 12 months ]
- Progression-free Survival [ Time Frame: start of treatment to disease progression, up to 12 months ]
- Overall Survival [ Time Frame: Up to 12 months ]
- Grade 3-5 Adverse Events [ Time Frame: Up to week 13 ]Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)
- Symptom Assessment (Measured by FACT-L Symptom Assessment Scale) [ Time Frame: baseline ]The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained.
- Symptom Assessment (Measured by FACT-L Symptom Assessment Scale) [ Time Frame: week 6 ]The higher the score, the greater the symptoms. The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained. Symptoms were measured following 2 21-day cycles of chemotherapy.
- Symptom Assessment (Measured by FACT-L Symptom Assessment Scale) [ Time Frame: week 12 ]The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. Symptoms were measured following 4 21-day cycles of chemotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590003
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Rogerio Lilenbaum, MD||Yale University|