Phase 2
N=33
BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01243775 ↗Enrolled (actual)
33
Serious AEs
30.3%
Results posted
Aug 2015
Primary outcome: Primary: Response Rate — 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Belotaxel (Drug); Belloxa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chonnam National University Hospital
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
11 | — |
| SECONDARY Progression Free Survival |
3.6 | — |
| SECONDARY Overall Survival |
10.9 | — |
| SECONDARY Neutropenia Grade 3-4 |
17 | — |
Summary
Lung cancer is the leading cause of cancer death in Korea as well as in other countries. About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and safety of docetaxel and oxaliplatin for patients with NSCLC.
Eligibility Criteria
Inclusion Criteria
- Stage IIIB/IV or Relapsed NSCLC
- Age >= 18 years
- At least one measurable lesion by RECIST (version 1.1)
- ECOG PS 0, 1, 2
- Hematologic profile
- Hgb > 8 g/dL, ANC >= 2,000/m3, Platelet >= 100,000/m3
- Hepatic profile
- Total bilirubin = grade 2 by NCI CTCAE 4.0
- Uncontrolled hypertension, Acute myocardial infarction within 6 months Unstable angina, Congestive heart failure >= NYHA grade 2 Uncontrolled significant arrhythmia
- Patients who entered other clinical trials within 4 weeks
- Pregnant or lactating women. women with child bearing age who are not willing to a contraceptive measure
Data sourced from ClinicalTrials.gov (NCT01243775). 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.