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

Non-Small Cell Lung Cancer Clinical Trial

— BELOXAN  

Official title:

Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243775
• Other study ID #: m601NSC10B
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2010
• Last updated: July 20, 2015
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: July 2015
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Belotaxel
60 mg/m2 3 weekly (day 1)
• Belloxa
70 mg/m2 3 weekly (day 2)

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeonnam

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Ban H, Kim KS, Oh IJ, Yoon SH, Lee B, Yu J, Kim S, Lee HS, Shin HJ, Park CK, Kwon YS, Kim YI, Lim SC, Kim YC. Efficacy and safety of docetaxel plus oxaliplatin as a first-line chemotherapy in patients with advanced or metastatic non-small cell lung cancer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	RECIST version 1.1	6th week	No
Secondary	Progression Free Survival		2 years	No
Secondary	Overall Survival		2 years	No
Secondary	Neutropenia Grade 3-4	Toxicity (CECAE ver 4.0) and Safety	2 years	Yes