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Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma

Phase 2
Open (Enrolling)
Renal Cell Carcinoma, Kidney Cancer

Thank you

Trial Information

Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma

Gemcitabine and capecitabine are designed to disrupt the growth of cancer cells, which may
cause cancer cells to start to die. Bevacizumab is a drug that binds to and inhibits
Vascular Endothelial Growth Factor (VEGF), a blood-vessel stimulating agent with unusually
high levels in kidney cancer.

If you are found to be eligible to take part in this study, you will receive gemcitabine,
capecitabine, and bevacizumab on a 28 day cycle. Capecitabine will be taken by mouth (with
food), twice daily, on Days 1-21. Gemcitabine will be given through a needle in your vein
in your arm over 30 minutes on Days 1 and 15. Bevacizumab will be given through a needle in
your vein in your arm on Days 1 and 15. It will be given over 120 minutes for Cycle 1 and
over 60 minutes for all other cycles. Your doctor may decided to give you bevacizumab over
30 minutes if you tolerate the treatment well.

On the first day of each cycle, blood (about 2 teaspoons) and a urine will be collected
before treatment for routine tests. You will also have blood drawn on Day 15 (about 2
teaspoons) for routine tests.

Every 8 weeks, you will have a CT scan of your chest, abdomen, and pelvis and a chest x-ray.
You will be asked about any drugs that you are currently taking and you will have a
complete physical exam. You will be asked about any side effects that you might have
experienced since the last visit and your ability to perform daily activities will be
evaluated. Repeat bone scans and MRI of the brain may be done if your doctor thinks it is

You will continue receiving treatment for a maximum of 12 months. However, if you are
benefitting from treatment, you may be able to continue receiving it off study. You will be
taken off study if the disease gets worse, if the side effects are intolerable, or if you
develop another illness that prevents you from receiving the treatment.

This is an investigational study. Gemcitabine, capecitabine, and bevacizumab are all FDA
approved and commercially available. Up to 40 participants may take part in this study.
All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Histologically demonstrated, metastatic or unresectable sarcomatoid carcinoma of the
kidney, defined as the following: • A tumor biopsy (primary or metastasis) must show
at least one focus of RCC (one of the recognized types); and, • A tumor biopsy
(primary or metastasis) must have at least 10% of the sample showing sarcomatoid

2. (# 1 cont'd) • Patients with primary tumor in place are eligible if there is any
percentage of sarcomatoid dedifferentiation on a needle biopsy (primary or
metastasis), and the radiographic appearance of the primary tumor on CT scan is
typical of RCC. For these patients, due to the small tumor sample, it is not required
to identify an area of typical RCC histology as long as the morphologic and
immunostaining characteristics are consistent with RCC.

3. At least one site of measurable disease (may include primary tumor).

4. No prior cytotoxic chemotherapy. Any prior immunotherapy is permitted.

5. No prior bevacizumab treatment. Prior sorafenib or sunitinib is permitted.

6. Zubrod performance status 2 or better

7. Adequate organ and bone marrow function: • ANC >/= 1,500 • Platelets >/=100,000 •
Total bilirubin clearance > 50 cc/min (measured or calculated by Cockcroft formula: Creatinine
Clearance = [(140 - age) x wt (kg)]/[72 x creat (mg/dl)], for females x 0.85.
Patients with creatinine clearance of 30-50 ml/min are eligible with an initial
dose-reduction of capecitabine to the (-1) dose level.

8. Female patients of childbearing potential (last menses < 2 years) must have a
negative blood pregnancy test within 7 days prior to starting treatment.

9. All patients must agree to practice adequate contraception if sexually active for the
duration of the trial and for 2 months after discontinuation of the study drugs

10. Written informed consent.

Exclusion Criteria:

1. Patients with history of myocardial infarction, transient ischemic attack (TIA),
stroke, pulmonary embolism, or history of deep vein thrombosis within the preceding
12 months.

2. Patients with major risk of bleeding, such as active brain metastases. Patients with
controlled or small brain metastases will be eligible based on clinical assessment of
the actual bleeding risk.

3. Patients with history of any major surgical procedure within the preceding 28 days.

4. Patients with baseline blood pressure >/= 140 systolic or >/= 90 diastolic.

5. Patients with nephrotic syndrome (proteinuria > 2 grams per 24 hours)

6. History of other malignancy, unless it is clinically non-threatening (such as
non-melanoma skin cancer) or controlled for 2 years prior to study entry.

7. Prior treatment with gemcitabine, capecitabine, or any fluoropyrimidine.

8. Prior unanticipated severe reaction to fluoropyrimidine therapy or known
hypersensitivity to 5-FU.

9. Any concurrent chemotherapy or radiotherapy.

10. Lack of physical integrity of the upper gastrointestinal tract, inability to swallow
tablets or those who have malabsorption syndrome.

11. Clinically significant cardiac disease not well controlled with medication, such as
symptomatic coronary artery disease, congestive heart failure, and cardiac

12. Serious concurrent infections or other serious medical conditions, including
uncontrolled diabetes.

13. Any serious non-healing wound, ulcer, or active bone fracture.

14. Any concurrent coumadin therapy. Patients who were previously on coumadin maintenance
may switch to aspirin or low-molecular-weight heparin.

15. Patients who have had an organ allograft.

16. Unwillingness to give written informed consent.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients with Event Free Survival

Outcome Description:

Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome Time Frame:

Baseline and with each 4 week cycle or until disease progression

Safety Issue:


Principal Investigator

Lance Pagliaro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney Cancer
  • Genitourinary
  • Kidney Cancer
  • Sarcomatoid Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • RCC
  • Sarcomatoid Carcinoma of the Kidney
  • Unresectable renal cell carcinoma
  • Capecitabine
  • Xeloda
  • Gemcitabine
  • Gemzar
  • Bevacizumab
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
  • Avastin
  • Vascular Endothelial Growth Factor
  • VEGF
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030