Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.

Detailed Description
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This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive: oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15 docetaxel 30mg/m2 on Days 1 and 8 Cycles are to be repeated every 28 days for a maximum of 6 cycles.

Official Title
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Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Oxaliplatin + Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) Patients must have measurable disease Age greater than or equal to 18 years ECOG performance score of 0, 1, or 2 Absolute neutrophil count (ANC) > 1,500 Platelets > 100,000 Serum creatinine < 1.5mg/dL Serum total bilirubin < 1.5mg/dL Alkaline phosphatase < 3 times the upper limit of normal SGOT/SGPT < 3 times the upper limit of normal Patients must be recovered from the effects of any prior surgery or RT. Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial. Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications. Exclusion Criteria: Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial. History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel Patients who have had prior chemotherapy for lung cancer Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment Grade 2 peripheral neuropathy Patients who are pregnant or lactating Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results History of allogeneic transplant Known HIV, hepatitis B or C (active, previously treated, or both)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. | Drug: Oxaliplatin + Docetaxel<br>* Oxaliplatin 85mg/m2 Docetaxel 30mg.m2<br>* Other names: Eloxatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD. | Response is measured every 2 cycles until disease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression | Progression is measured from each participants start of study until removal from treatment. | <1 cycle to 6 cycles of treatment | 
| Duration of Response | Duration of response is a measure of how long the participants response to therapy was maintained. | 0 -12 months | 
| Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle. | day one of cycle one until participant removed from trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non small Cell Lung Cancer Stage IIIb and IV