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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 19, 2010
Last Update Posted: August 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital
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.

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Belotaxel Drug: Belloxa Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Young-Chul Kim, Chonnam National University Hospital:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 6th week ]
    RECIST version 1.1

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ]
  • Overall Survival [ Time Frame: 2 years ]
  • Neutropenia Grade 3-4 [ Time Frame: 2 years ]
    Toxicity (CECAE ver 4.0) and Safety

Enrollment: 33
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belotaxel plus Belloxa
Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Drug: Belotaxel
60 mg/m2 3 weekly (day 1)
Other Name: Docetaxel
Drug: Belloxa
70 mg/m2 3 weekly (day 2)
Other Name: Oxaliplatin


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01243775

Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Jeonnam, Korea, Republic of, 519-809
Sponsors and Collaborators
Chonnam National University Hospital
Chong Kun Dang Pharmaceutical
Principal Investigator: Young-Chul Kim, MD, PhD Chonnam National University Hospital
  More Information

Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01243775     History of Changes
Other Study ID Numbers: m601NSC10B
First Submitted: November 15, 2010
First Posted: November 19, 2010
Results First Submitted: July 19, 2015
Results First Posted: August 17, 2015
Last Update Posted: August 17, 2015
Last Verified: July 2015

Keywords provided by Young-Chul Kim, Chonnam National University Hospital:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action