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

Chonnam National University

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Belloxa

Drug: Belotaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01243775

m601NSC10B

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No 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