A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- combination of gemcitabine, capecitabine, and bevacizumab
- Conditions
- Carcinoma, Renal Cell
- Sponsor
- University of Chicago
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
I
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
Intervention: combination of gemcitabine, capecitabine, and bevacizumab
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 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
Time Frame: 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 Outcomes
- Overall Survival(60 months)