A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01497041
• Other study ID #: KSWOG 2010-3
• Status: Recruiting
• Phase: Phase 2
• First received: December 14, 2011
• Last updated: December 19, 2011
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2011
• Source: Korean South West Oncology Group
• Contact: Sang Byung Bae
• Phone: +82-41-570-3667
• Email: baesan[@]schmc.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

1. Goals

The primary goal of this phase II trial is to:

evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment

Secondary goals are to:

evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population

2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically

2. Patients must be = 18 years old of age

3. ECOG performance status = 1

4. Estimated life expectancy of more than 3 months

5. Treatment with only one prior chemotherapy

6. At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

7. Adequate bone marrow function (absolute neutrophil count [ANC] = 1,500/µL, hemoglobin = 9.0 g/dL [correction by transfusion is acceptable], and platelets = 100,000/µL)

8. Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])

9. Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)

10. Provision of fully informed consent prior to any study specific procedures

Exclusion Criteria:

1. Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception

2. Patients who received prior chemotherapy including paclitaxel or docetaxel

3. Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for =5 years)

4. Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases

5. Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (= Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study

6. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Large Cell
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous
• Carcinoma, Squamous Cell

Intervention

Drug:
• Docetaxel
Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
• Oxaliplatin
Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Korean South West Oncology Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Assessment of response will be assessed according to RECIST v1.1 criteria	2years	No
Secondary	Overall survival	Overall survival will be calculated by Kaplan-Meier method	2years	No
Secondary	Progression free survival	Progression free survival will be calculated by Kaplan-Meier method	2 years	No
Secondary	Number of Participants with Adverse Events	Assessment of toxicity will be assessed according to CTCAE version 4.0	2 years	Yes
Secondary	Quality of life	Quality of life will be assessed according to EORTC QLQ-C30, LC13	2 years	No