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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Eli Lilly and Company
• Treatments: Antibodies; Antibodies, Monoclonal; Bevacizumab; Capecitabine; Gemcitabine

Criteria

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 bilirubinnormal • 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.