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

NCT01243775 | Completed Phase 2 Results DMC

• 1 other identifier: m601NSC10B
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Response Rate

  RECIST version 1.1

  6th week

Secondary Outcomes (3)

• Progression Free Survival

  2 years

• Overall Survival

  2 years

• Neutropenia Grade 3-4

  2 years

Study Arms (1)

Belotaxel plus Belloxa

EXPERIMENTAL

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

Drug: Belotaxel; Drug: Belloxa

Interventions

Belotaxel DRUG

60 mg/m2 3 weekly (day 1)

Also known as: Docetaxel

Belotaxel plus Belloxa

Belloxa DRUG

70 mg/m2 3 weekly (day 2)

Also known as: Oxaliplatin

Belotaxel plus Belloxa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Chong Kun Dang Pharmaceutical: collaborator

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 519-809, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26767047 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Oxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Dr. Young-Chul Kim
• Organization: Chonnam National University Hwasun Hospital

kyc0923@jnu.ac.kr

82-61-379-7614

Study Officials

• Young-Chul Kim, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 17, 2015
• Results First Posted: August 17, 2015

Record last verified: 2015-07

Locations

KR (1)