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
This study is currently recruiting participants.
Verified December 2011 by Korean South West Oncology Group
Sponsor:
Korean South West Oncology Group
Information provided by (Responsible Party):
Korean South West Oncology Group
ClinicalTrials.gov Identifier:
NCT01497041
First received: December 14, 2011
Last updated: December 19, 2011
Last verified: December 2011
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Purpose
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
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Carcinoma, Large Cell |
Drug: Docetaxel Drug: Oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Korean South West Oncology Group:
Primary Outcome Measures:
- Response rate [ Time Frame: 2years ] [ Designated as safety issue: No ]Assessment of response will be assessed according to RECIST v1.1 criteria
Secondary Outcome Measures:
- Overall survival [ Time Frame: 2years ] [ Designated as safety issue: No ]Overall survival will be calculated by Kaplan-Meier method
- Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progression free survival will be calculated by Kaplan-Meier method
- Number of Participants with Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Assessment of toxicity will be assessed according to CTCAE version 4.0
- Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]Quality of life will be assessed according to EORTC QLQ-C30, LC13
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Docetaxel
Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
Drug: Oxaliplatin
Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
- Patients must be ≥ 18 years old of age
- ECOG performance status ≤ 1
- Estimated life expectancy of more than 3 months
- Treatment with only one prior chemotherapy
- At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- 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)
- Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
- Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)
- Provision of fully informed consent prior to any study specific procedures
Exclusion Criteria:
- Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
- Patients who received prior chemotherapy including paclitaxel or docetaxel
- 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)
- Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- 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
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497041
Contacts
| Contact: Sang Byung Bae | +82-41-570-3667 | baesan@schmc.ac.kr |
| Contact: Hwan Jung Yun | +82-42-280-7157 | hjyun@cnu.ac.kr |
Locations
| Korea, Republic of | |
| Soonchunhyang University Cheonan Hospital | Recruiting |
| Cheonan, Korea, Republic of | |
| Contact: Sang Byung Bae, M.D. +82-41-570-3667 baesan@schmc.ac.kr | |
| Principal Investigator: Sang Byung Bae, M.D. | |
| Sub-Investigator: Han Jo Kim, M.D. | |
| Sub-Investigator: Kyu Taek Lee, M.D. | |
| Chungbuk National University Hospital | Recruiting |
| Cheongju, Korea, Republic of | |
| Contact: Ki Hyeong Lee +82-43-269-6015 kihlee@chungbuk.ac.kr | |
| Sub-Investigator: Hye Suk Han | |
| Principal Investigator: Ki Hyeong Lee | |
| Chungnam National University Hospital | Recruiting |
| Daejeon, Korea, Republic of | |
| Contact: Hwan Jung Yun +82-42-280-7157 hjyun@cnuh.co.kr | |
| Principal Investigator: Hwan Jung Yun | |
| Sub-Investigator: Sam Yong Kim | |
| Sub-Investigator: Hyo Jin Lee | |
| The Catholic University of Korea Daejeon ST. Mary's Hospital | Recruiting |
| Daejeon, Korea, Republic of | |
| Contact: Suk Young Park +82-42-220-9832 sypark1011@hotmail.com | |
| Principal Investigator: Suk Young Park | |
| Sub-Investigator: Young Joon Yang | |
| Sub-Investigator: Ji Chan Park | |
| Chonbuk National University Hospital | Recruiting |
| Jeonju, Korea, Republic of | |
| Contact: Eun-Kee Song +82-63-254-1609 eksong@jbnu.ac.kr | |
| Principal Investigator: Eun-Kee Song | |
| Sub-Investigator: Chang-Yeol Yim | |
| Sub-Investigator: Na-Ri Lee | |
Sponsors and Collaborators
Korean South West Oncology Group
Investigators
| Principal Investigator: | Sang Byung Bae, M.D. | Soonchunhyang University Cheonan Hospital |
More Information
No publications provided
| Responsible Party: | Korean South West Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01497041 History of Changes |
| Other Study ID Numbers: | KSWOG 2010-3 |
| Study First Received: | December 14, 2011 |
| Last Updated: | December 19, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Lung Neoplasms Carcinoma, Large Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neoplasms, Squamous Cell Oxaliplatin Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013