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

• Sponsor: Chonnam National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01243775
• Collaborator: Chong Kun Dang Pharmaceutical (Industry)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: Belotaxel; Drug: Belloxa	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belotaxel plus Belloxa Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)	Drug: Belotaxel; 60 mg/m2 3 weekly (day 1); Other Names: Docetaxel ; Drug: Belloxa; 70 mg/m2 3 weekly (day 2); Other Names: Oxaliplatin

Outcome Measures

Primary Outcome Measures

1. Response Rate [6th week]

   RECIST version 1.1

Secondary Outcome Measures

1. Progression Free Survival [2 years]

2. Overall Survival [2 years]

3. Neutropenia Grade 3-4 [2 years]

   Toxicity (CECAE ver 4.0) and Safety

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonnam National University Hwasun Hospital	Hwasun	Jeonnam	Korea, Republic of	519-809

Sponsors and Collaborators

• Chonnam National University Hospital
• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Young-Chul Kim, MD, PhD, Chonnam National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital
• ClinicalTrials.gov Identifier: NCT01243775
• Other Study ID Numbers: m601NSC10B
• First Posted: Nov 19, 2010
• Last Update Posted: Aug 17, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Young-Chul Kim, Professor, Chonnam National University Hospital: NSCLC
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Docetaxel; Oxaliplatin

Study Results

Participant Flow

Arm/Group Title	Belotaxel Plus Belloxa
Arm/Group Description	Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Period Title: Overall Study
STARTED	33
COMPLETED	31
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Belotaxel Plus Belloxa
Arm/Group Description	Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Overall Participants	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.0 (9.7)
Sex: Female, Male (Count of Participants)
Female	3 9.1%
Male	30 90.9%
Race/Ethnicity, Customized (participants) [Number]
Korean	33 100%
Region of Enrollment (participants) [Number]
Korea, Republic of	33 100%

Outcome Measures

1. Primary Outcome

Title	Response Rate
Description	RECIST version 1.1
Time Frame	6th week

Outcome Measure Data

Analysis Population Description

Intention to treat population

Arm/Group Title	Belotaxel Plus Belloxa
Arm/Group Description	Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Measure Participants	33
Number [participants]	11 33.3%

2. Secondary Outcome

Title	Progression Free Survival
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belotaxel Plus Belloxa
Arm/Group Description	Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Measure Participants	33
Median (95% Confidence Interval) [months]	3.6

3. Secondary Outcome

Title	Overall Survival
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belotaxel Plus Belloxa
Arm/Group Description	Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Measure Participants	33
Median (95% Confidence Interval) [months]	10.9

4. Secondary Outcome

Title	Neutropenia Grade 3-4
Description	Toxicity (CECAE ver 4.0) and Safety
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belotaxel Plus Belloxa
Arm/Group Description	Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Measure Participants	33
Number [participants]	17 51.5%

Adverse Events

Time Frame	4 months
Arm/Group Title	Belotaxel Plus Belloxa
Arm/Group Description	Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
All Cause Mortality
	Belotaxel Plus Belloxa
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Belotaxel Plus Belloxa
	Affected / at Risk (%)	# Events
Total	10/33 (30.3%)
Blood and lymphatic system disorders
Febrile Neutropenia	2/33 (6.1%)	2
Infections and infestations
Infection	7/33 (21.2%)	7
Vascular disorders
Thromboembolism	1/33 (3%)	1
Other (Not Including Serious) Adverse Events
	Belotaxel Plus Belloxa
	Affected / at Risk (%)	# Events
Total	33/33 (100%)
Gastrointestinal disorders
Anorexia	21/33 (63.6%)
Diarrhea	12/33 (36.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.