Phase 2
Completed N=7
Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC
Source: ClinicalTrials.gov NCT00647426 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin
Summary
This is an open-label, single institution, phase II study of Sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. Chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin |
— | — |
| SECONDARY Number of Participants the Progression-free Survival (PFS) . |
— | — |
| SECONDARY Number of Participants With Serious Adverse Events |
— | — |
| SECONDARY The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed NSCLC with clinical or radiological evidence of advanced disease (Stage IIIB/IV)
- Uni-dimensionally measurable disease
- Age => 18 years
- ECOG performance status of 0-1
- Life expectancy > 3 months
Exclusion Criteria
- Small-cell or mixed histologies including a small cell component
- Prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease
- Patients with peripheral neuropathy grade => 2
Data sourced from ClinicalTrials.gov (NCT00647426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.