BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Belotaxel; Drug: Belloxa

• Registration Number: NCT01243775
• Lead Sponsor: Chonnam National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-07
• Results First Submitted: 2015-07-19
• Results First Submitted QC: 2015-07-20
• Last Update Submitted: 2015-07-20
• Results First Posted: 2015-08-17
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 <= 1.5 x upper normal value
  • Transaminases <= 3 x upper normal value <= 5 x upper normal value in case of liver metastasis

• Creatinine <= 1.5mg/dL

• Patients should be recovered from toxicities of previous treatment.

• Written informed consent by patient or surrogates

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Exclusion Criteria

• Patients who had been previously treated with chemotherapy for NSCLC
• Active infection requiring antibiotics treatment
• Prior diagnosis of other malignancy except radically treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix
• Peripheral neuropathy >= 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Belotaxel plus Belloxa	Belotaxel	Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Belotaxel plus Belloxa	Belloxa	Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)

Primary Outcome Measures

Name	Time	Method
Response Rate	6th week	RECIST version 1.1

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	2 years
Overall Survival	2 years
Neutropenia Grade 3-4	2 years	Toxicity (CECAE ver 4.0) and Safety

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Jeonnam, Korea, Republic of