Non-Small Cell Lung CancerPhase 2BELOXANNCT01243775
BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC
A Phase 2 study testing Belotaxel and Belloxa in people with Non-Small Cell Lung Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Belotaxel and Belloxa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 519-809
About this study
Official title: Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Belotaxel, Belloxa
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelotaxelDrug
Also called Docetaxel
60 mg/m2 3 weekly (day 1)
BelloxaDrug
Also called Oxaliplatin
70 mg/m2 3 weekly (day 2)
| Study group | Role | What they receive |
|---|---|---|
| Belotaxel plus Belloxa | Experimental | Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2) Receives: Drug: Belotaxel; Drug: Belloxa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
RECIST version 1.1
Measured: 6th week
Secondary outcomes (3)
Progression Free Survival
Measured: 2 years
Overall Survival
Measured: 2 years
Neutropenia Grade 3-4
Toxicity (CECAE ver 4.0) and Safety
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Responsible party
- Principal investigator, Young-Chul Kim, Chonnam National University Hospital
- Investigators
- Young-Chul Kim, MD, PhD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243775
- Sponsor's protocol ID
- m601NSC10B
- Acronym
- BELOXAN
- Status last verified
- Jul 2015
- First submitted
- 15 Nov 2010
- Last updated
- 17 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26767047
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01243775
- Acronym / sponsor ID
- BELOXAN / m601NSC10B
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Posted 17 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belotaxel plus Belloxa | Experimental | Drug: Belotaxel, Drug: BelloxaBelotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelotaxelAlso: Docetaxel60 mg/m2 3 weekly (day 1) | Drug | Belotaxel plus Belloxa |
| BelloxaAlso: Oxaliplatin70 mg/m2 3 weekly (day 2) | Drug | Belotaxel plus Belloxa |
Primary outcome
Response Rate
Time frame: 6th week
RECIST version 1.1
3 secondary outcomes
Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Neutropenia Grade 3-4
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26767047Ban 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Chul Kim, MD, PhD principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belotaxel and Belloxa in people with Non-Small Cell Lung Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01243775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.