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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523640
• Other study ID #: 13662A
• Status: Terminated
• Phase: Phase 2
• First received: August 30, 2007
• Last updated: January 16, 2014
• Start date: March 2005
• Est. completion date: April 2011

Study information

• Verified date: January 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Overall Survival	Time from enrollment until death from any cause.	60 months	No