A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to find out what effects (good and bad) the combination of the chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney cancer.

Detailed Description
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to determine the objective response rate and estimate the time to progression of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic clear cell renal cell cancer; to determine survival of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic cell renal cell cancer; to determine the toxicity of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic renal cell cancer; to collect baseline serum and plasma samples for exploration of possible prognostic and predictive markers

Official Title
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A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: combination of gemcitabine, capecitabine, and bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed metastatic clear cell renal cell cancer Measurable disease Age 18 or older ECOG performance status of 0 - 1 Blood pressure less than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart Normal organ function Women of child-bearing potential and men must agree to use adequate contraception Ability to understand and the willingness to sign a written informed consent document and to follow all required study procedures Exclusion Criteria: Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients may not have had prior treatment with pyrimidine analogs or VEGF binding agents Patients may not be receiving any other investigational or therapeutic agents Patients may not be receiving therapeutic anticoagulation with warfarin, its congeners, heparin, low molecular weight heparinoids, specific thrombin inhibitors, or other similar agents Patients receiving low dose coumadin (1 mg daily) for central line patency are eligible Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment start, or anticipation of need for major surgical procedure during the course of the study Fine needle aspirations or core biopsies within 7 days prior to treatment start are acceptable Serious, nonhealing wound, ulcer, or bone fracture Evidence of bleeding diathesis or coagulopathy Patients with known brain metastases Uncontrolled intercurrent illness Pregnant women HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Combination of gemcitabine, capecitabine, and bevacizumab gemcitabine 1000 mg/m^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle | Drug: combination of gemcitabine, capecitabine, and bevacizumab<br>* gemcitabine 1000 mg/m^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR. | 12 weeks | 
| Progression-free Survival | Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from enrollment until death from any cause. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, renal cell, kidney, neoplasm