A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

Study Overview
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Brief Summary
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This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.

Detailed Description
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Rationale: Docetaxel has some efficacy against non-small cell lung cancer (NSCLC). This drug is Food and Drug Administration approved in combination with cisplatin (Platinol) for the treatment of unresectable, locally advanced or metastatic NSCLC in patients who have not previously had chemotherapy for this condition. Docetaxel is also approved for second line treatment of metastatic NSCLC. Research indicates that capecitabine, in combination with docetaxel, has efficacy against NSCLC. Capecitabine appears to have anti-cancer activity through several enzymes. This drug is metabolized in the body to another agent called 5-FU. During this conversion process, 5-FU requires thymidine phosphorylase (TP), a cellular characteristic associated with tumor growth. There are higher levels of TP expression in tumors as compared to normal tissue. The drug administration schedule in this study is designed to optimize efficacy against the TP target through both docetaxel and capecitabine. This study will measure biological changes to TP and other enzymes to help researchers gain more information about how capecitabine and docetaxel works against NSCLC. Purpose: This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC. Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies. Treatment: Patients in this study will receive docetaxel and capecitabine. Docetaxel will be administered through intravenous infusions. Capecitabine will be provided through oral pills. A four-week period constitutes one cycle. Docetaxel will be given weekly for three weeks followed by one week of rest. Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Official Title
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A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

Conditions
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Lung Cancer, Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Capecitabine
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have advanced NSCLC No prior chemotherapy Eastern Cooperative Oncology Group(ECOG)Performance Status:0 or 1 Must have measurable disease (RECIST criteria) life expectancy of at least 12 weeks adequate organ function including Exclusion Criteria: Pregnant or lactating women Psychiatric disorders that would interfere w/consent or follow-up Patients with uncontrolled diabetes mellitus, defined as random blood sugar > 250mg/dL.

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: Docetaxel and Capecitabine<br> | Drug: Capecitabine<br>* 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.<br>* Other names: Xeloda;Drug: Docetaxel<br>* 36 mg/m2 IV weekly for 3 weeks every 4 weeks.<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Objective Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Every 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression |  | Every 35 days | 
| One Year Survival |  | one year | 
| Pharmacokinetics |  | Cycle 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced, Previously Untreated