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| Name | Class |
|---|---|
| Chong Kun Dang Pharmaceutical | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belotaxel plus Belloxa | Experimental | Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belotaxel | Drug | 60 mg/m2 3 weekly (day 1) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | RECIST version 1.1 | 6th week |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 2 years | |
| Overall Survival | 2 years | |
| Neutropenia Grade 3-4 |
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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
Hepatic profile
Creatinine <= 1.5mg/dL
Patients should be recovered from toxicities of previous treatment.
Written informed consent by patient or surrogates
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Chul Kim, MD, PhD | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | 519-809 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26767047 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Belotaxel Plus Belloxa | Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belotaxel Plus Belloxa | Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate | RECIST version 1.1 | Intention to treat population | Posted | Number | participants | 6th week |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belotaxel Plus Belloxa | Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Young-Chul Kim | Chonnam National University Hwasun Hospital | 82-61-379-7614 | kyc0923@jnu.ac.kr |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Belloxa | Drug | 70 mg/m2 3 weekly (day 2) |
|
|
Toxicity (CECAE ver 4.0) and Safety
| 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Progression Free Survival | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | Neutropenia Grade 3-4 | Toxicity (CECAE ver 4.0) and Safety | Posted | Number | participants | 2 years |
|
|
|
| 10 |
| 33 |
| 33 |
| 33 |
| Thromboembolism | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |