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OpenTrials
Completed

NCT Number: NCT01243775

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 519-809, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belotaxel

Drug

60 mg/m2 3 weekly (day 1)

Other names: Docetaxel

Belloxa

Drug

70 mg/m2 3 weekly (day 2)

Other names: Oxaliplatin

Primary outcomes

  1. Response Rate

    Time frame: 6th week

    RECIST version 1.1

Secondary outcomes

  1. Progression Free Survival

    Time frame: 2 years

  2. Overall Survival

    Time frame: 2 years

  3. Neutropenia Grade 3-4

    Time frame: 2 years

    Toxicity (CECAE ver 4.0) and Safety

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • Chong Kun Dang Pharmaceutical

Registry information

Official study title

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

Acronym: BELOXAN

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 19, 2010
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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