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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

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


- 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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate

Outcome 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.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Walter Stadler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

13662A

NCT ID:

NCT00523640

Start Date:

March 2005

Completion Date:

April 2011

Related Keywords:

  • Carcinoma, Renal Cell
  • metastatic
  • renal cell
  • kidney
  • neoplasm
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

University of ChicagoChicago, Illinois  60637