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

Phase 2

Terminated

Interventions: Drug: combination of gemcitabine, capecitabine, and bevacizumab

Brief Summary: 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: * 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
I	combination of gemcitabine, capecitabine, and bevacizumab	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

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	12 weeks	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.
Progression-free Survival	60 months	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

Secondary Outcome Measures