Clinical trial NCT00523640: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: metastatic
renal cell
kidney
neoplasm
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Eli Lilly and Company
First posted: 2007-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 12 weeks
measure: Progression-free Survival
timeFrame: 60 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Walter Stadler, MD
role: PRINCIPAL_INVESTIGATOR
References: