Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Sarcomatoid Renal Cell Carcinoma
Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma
2 other identifiers
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 3, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
June 22, 2017
CompletedJuly 19, 2017
June 1, 2017
8.8 years
July 3, 2007
May 26, 2017
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS)
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.
12 months or until progression of disease
Time to Treatment Failure (TTF)
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.
12 months or until progression of disease
Secondary Outcomes (1)
Objective Response Rate (ORR)
12 months or until progression of disease
Study Arms (1)
Capecitabine + Gemcitabine + Bevacizumab
EXPERIMENTALCapecitabine 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.
Interventions
800 mg/m\^2 By Mouth Twice Daily On Days 1-21.
900 mg/m\^2 By Vein Over 30 Minutes on Days 1 and 15.
10 mg/kg By Vein On Days 1 and 15.
Eligibility Criteria
You may qualify if:
- 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.
- (# 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.
- At least one site of measurable disease (may include primary tumor).
- No prior cytotoxic chemotherapy. Any prior immunotherapy is permitted.
- No prior bevacizumab treatment. Prior sorafenib or sunitinib is permitted.
- Zubrod performance status 2 or better
- 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.
- Female patients of childbearing potential (last menses \< 2 years) must have a negative blood pregnancy test within 7 days prior to starting treatment.
- 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
- Written informed consent.
You may not qualify if:
- Patients with history of myocardial infarction, transient ischemic attack (TIA), stroke, pulmonary embolism, or history of deep vein thrombosis within the preceding 12 months.
- 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.
- Patients with history of any major surgical procedure within the preceding 28 days.
- Patients with baseline blood pressure \>/= 140 systolic or \>/= 90 diastolic.
- Patients with nephrotic syndrome (proteinuria \> 2 grams per 24 hours)
- 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.
- Prior treatment with gemcitabine, capecitabine, or any fluoropyrimidine.
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU.
- Any concurrent chemotherapy or radiotherapy.
- Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
- Clinically significant cardiac disease not well controlled with medication, such as symptomatic coronary artery disease, congestive heart failure, and cardiac arrhythmias.
- Serious concurrent infections or other serious medical conditions, including uncontrolled diabetes.
- Any serious non-healing wound, ulcer, or active bone fracture.
- Any concurrent coumadin therapy. Patients who were previously on coumadin maintenance may switch to aspirin or low-molecular-weight heparin.
- Patients who have had an organ allograft.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Eli Lilly and Companycollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nazir Tannir/
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nizar M. Tannir, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2007
First Posted
July 4, 2007
Study Start
July 1, 2007
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 19, 2017
Results First Posted
June 22, 2017
Record last verified: 2017-06