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

This study has been completed.
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01243775
First received: November 15, 2010
Last updated: July 20, 2015
Last verified: July 2015
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Chonnam National University Hospital:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 6th week ] [ Designated as safety issue: No ]
    RECIST version 1.1


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Neutropenia Grade 3-4 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 <= 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243775

Locations
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
Investigators
Principal Investigator: Young-Chul Kim, MD, PhD Chonnam National University Hospital
  More Information

Publications:
Ban H, Kim K, Oh I, et al. Efficacy and safety of docetaxel plus oxaliplatin as a first-line chemotherapy in patients with advanced or metastatic non-small cell lung cancer. Thoracic cancer 5(6):525-529, 2014

Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01243775     History of Changes
Other Study ID Numbers: m601NSC10B
Study First Received: November 15, 2010
Results First Received: July 19, 2015
Last Updated: July 20, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonnam National University Hospital:
NSCLC

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

ClinicalTrials.gov processed this record on August 26, 2015