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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Belotaxel
Belloxa
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Belotaxel plus Belloxa

Arm Description

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

Outcomes

Primary Outcome Measures

Response Rate
RECIST version 1.1

Secondary Outcome Measures

Progression Free Survival
Overall Survival
Neutropenia Grade 3-4
Toxicity (CECAE ver 4.0) and Safety

Full Information

First Posted
November 15, 2010
Last Updated
July 20, 2015
Sponsor
Chonnam National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01243775
Brief Title
BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC
Acronym
BELOXAN
Official Title
Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belotaxel plus Belloxa
Arm Type
Experimental
Arm Description
Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Intervention Type
Drug
Intervention Name(s)
Belotaxel
Other Intervention Name(s)
Docetaxel
Intervention Description
60 mg/m2 3 weekly (day 1)
Intervention Type
Drug
Intervention Name(s)
Belloxa
Other Intervention Name(s)
Oxaliplatin
Intervention Description
70 mg/m2 3 weekly (day 2)
Primary Outcome Measure Information:
Title
Response Rate
Description
RECIST version 1.1
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
2 years
Title
Overall Survival
Time Frame
2 years
Title
Neutropenia Grade 3-4
Description
Toxicity (CECAE ver 4.0) and Safety
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Chul Kim, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeonnam
ZIP/Postal Code
519-809
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26767047
Citation
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. Thorac Cancer. 2014 Nov;5(6):525-9. doi: 10.1111/1759-7714.12123. Epub 2014 Oct 23.
Results Reference
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BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC

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