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Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Sarcomatoid Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496587
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : June 22, 2017
Last Update Posted : July 19, 2017
Eli Lilly and Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if the combination of 3 drugs (gemcitabine, capecitabine, and bevacizumab) can help to control metastatic or unresectable renal cell carcinoma. The safety of this drug combination will also be tested.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Kidney Cancer Drug: Capecitabine Drug: Gemcitabine Drug: Bevacizumab Phase 2

Detailed Description:

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 necessary.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma
Study Start Date : July 2007
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: Capecitabine + Gemcitabine + Bevacizumab
Capecitabine 800 mg/m^2 By Mouth Twice Daily On Days 1-21. Gemcitabine 900 mg/m^2 By Vein Over 30 Minutes on Days 1 and 15. Bevacizumab 10 mg/kg By Vein On Days 1 and 15.
Drug: Capecitabine
800 mg/m^2 By Mouth Twice Daily On Days 1-21.
Other Name: Xeloda

Drug: Gemcitabine
900 mg/m^2 By Vein Over 30 Minutes on Days 1 and 15.
Other Names:
  • Gemzar
  • Gemcitabine Hydrochloride

Drug: Bevacizumab
10 mg/kg By Vein On Days 1 and 15.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 12 months or until progression of disease ]
    Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.

  2. Time to Treatment Failure (TTF) [ Time Frame: 12 months or until progression of disease ]
    Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 12 months or until progression of disease ]
    Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 histology.
  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: • Absolute Neutrophil Count (ANC) >/= 1,500 • Platelets >/=100,000 • Total bilirubin </= 1.5 mg/dl • AST and ALT </= 3x upper limit normal • Creatinine 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 arrhythmias.
  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.

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 identifier (NCT number): NCT00496587

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eli Lilly and Company
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Principal Investigator: Nizar M. Tannir, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00496587    
Other Study ID Numbers: 2006-0433
NCI-2012-01511 ( Registry Identifier: NCI CTRP )
First Posted: July 4, 2007    Key Record Dates
Results First Posted: June 22, 2017
Last Update Posted: July 19, 2017
Last Verified: June 2017
Keywords provided by M.D. Anderson Cancer Center:
Kidney Cancer
Sarcomatoid Renal Cell Carcinoma
Renal Cell Carcinoma
Sarcomatoid Carcinoma of the Kidney
Unresectable renal cell carcinoma
Anti-VEGF monoclonal antibody
Vascular Endothelial Growth Factor
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors