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

Primary Purpose

Carcinoma, Renal Cell

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
combination of gemcitabine, capecitabine, and bevacizumab
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring metastatic, renal cell, kidney, neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Overall Survival
Time from enrollment until death from any cause.

Full Information

First Posted
August 30, 2007
Last Updated
January 16, 2014
Sponsor
University of Chicago
Collaborators
Genentech, Inc., Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00523640
Brief Title
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
Official Title
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Too slow accrual
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Genentech, Inc., Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
metastatic, renal cell, kidney, neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
combination of gemcitabine, capecitabine, and bevacizumab
Intervention Description
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 Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
12 weeks
Title
Progression-free Survival
Description
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
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Time from enrollment until death from any cause.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Stadler, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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