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

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ClinicalTrials.gov Identifier: NCT00523640
Recruitment Status : Terminated (Too slow accrual)
First Posted : August 31, 2007
Results First Posted : December 22, 2011
Last Update Posted : February 11, 2014
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: combination of gemcitabine, capecitabine, and bevacizumab Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
Study Start Date : March 2005
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011


Arm Intervention/treatment
Experimental: 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

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




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Overall Survival [ Time Frame: 60 months ]
    Time from enrollment until death from any cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523640


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Genentech, Inc.
Eli Lilly and Company
Investigators
Principal Investigator: Walter Stadler, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00523640     History of Changes
Other Study ID Numbers: 13662A
First Posted: August 31, 2007    Key Record Dates
Results First Posted: December 22, 2011
Last Update Posted: February 11, 2014
Last Verified: January 2014

Keywords provided by University of Chicago:
metastatic
renal cell
kidney
neoplasm

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Gemcitabine
Capecitabine
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors