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

• Sponsor: Korean South West Oncology Group (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01497041
• Collaborator: (none)
• Enrollment: 35
• Locations: 5
• Duration (Months): 34
• Patients Per Site: 7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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

1. 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 or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous; Carcinoma, Large Cell	Drug: Docetaxel; Drug: Oxaliplatin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Outcome Measures

Primary Outcome Measures

1. Response rate [2years]

   Assessment of response will be assessed according to RECIST v1.1 criteria

Secondary Outcome Measures

1. Overall survival [2years]

   Overall survival will be calculated by Kaplan-Meier method

2. Progression free survival [2 years]

   Progression free survival will be calculated by Kaplan-Meier method

3. Number of Participants with Adverse Events [2 years]

   Assessment of toxicity will be assessed according to CTCAE version 4.0

4. Quality of life [2 years]

   Quality of life will be assessed according to EORTC QLQ-C30, LC13

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soonchunhyang University Cheonan Hospital	Cheonan		Korea, Republic of
2	Chungbuk National University Hospital	Cheongju		Korea, Republic of
3	Chungnam National University Hospital	Daejeon		Korea, Republic of
4	The Catholic University of Korea Daejeon ST. Mary's Hospital	Daejeon		Korea, Republic of
5	Chonbuk National University Hospital	Jeonju		Korea, Republic of

Sponsors and Collaborators

• Korean South West Oncology Group

Investigators

• Principal Investigator: Sang Byung Bae, M.D., Soonchunhyang University Cheonan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Korean South West Oncology Group
• ClinicalTrials.gov Identifier: NCT01497041
• Other Study ID Numbers: KSWOG 2010-3
• First Posted: Dec 22, 2011
• Last Update Posted: Dec 22, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Large Cell; Docetaxel; Oxaliplatin

Study Results

No Results Posted as of Dec 22, 2011