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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belotaxel plus Belloxa

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

Group Type EXPERIMENTAL

Belotaxel

Intervention Type DRUG

60 mg/m2 3 weekly (day 1)

Belloxa

Intervention Type DRUG

70 mg/m2 3 weekly (day 2)

Interventions

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Belotaxel

60 mg/m2 3 weekly (day 1)

Intervention Type DRUG

Belloxa

70 mg/m2 3 weekly (day 2)

Intervention Type DRUG

Other Intervention Names

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Docetaxel Oxaliplatin

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No