Phase II Study for the Evaluation of Neoadjuvant Treatment With Cabozantinib Pior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer
Overview
- Phase
- Phase 2
- Intervention
- Cabozantinib
- Conditions
- Renal Cell Carcinoma Metastatic
- Sponsor
- Fundacion Oncosur
- Enrollment
- 18
- Locations
- 8
- Primary Endpoint
- Radiological response rate prior to cytoreductive nephrectomy
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC).
Detailed Description
Metastatic Renal cell carcinoma (RCC) is a type of kidney cancer that arises in the small tubes of the kidneys and has spread to other parts of the body (advanced cancer/metastases). Patients typically have surgery to remove a part or all of their kidney (called partial or radical nephrectomy). Other treatments include chemotherapy, targeted therapy, immunotherapy and hormone therapy and may be used before or after surgery or radiotherapy. There is no standard drug therapy given before surgery, but such preoperative therapy is used widely in the treatment of other cancer types. This approach has several potential advantages, including shrinking the tumor to help improve surgical outcomes and to help find an appropriate drug therapy. Cabozantinib is the generic for the trade chemotherapy drug CABOMETYX™ (cabozantinib). It is known as a cancer growth inhibitor and also an angiogenesis inhibitor. Tyrosine kinases are proteins that control how cells grow and divide. By blocking the activity of these proteins in cancer cells, the medicine reduces the growth and spread of cancer. This study tries to clarify whether Cabozantinib could be a safe and effective preoperative treatment in patients with advanced RCC who were candidates for removing a part or all of their kidney.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with locally advanced or metastatic renal cell carcinoma with a clear cell component confirmed histologically by biopsy.
- •Patients eligible for cytoreductive nephrectomy according to their surgical risk established in routine clinical practice at the site.
- •Age ≥ 18 years.
- •Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of between 0 and
- •Patients with appropriate organ and bone marrow function within 4 weeks prior to starting treatment with cabozantinib:
- •Leukocyte count \> 4,000 cells/μL
- •Hemoglobin \> 9 g/dL
- •Platelet count \> 100,000/mm3
- •Serum creatinine \< 2.0 mg/dL or serum creatinine clearance \> 30 mL/min (according to the Cockcroft-Gault formula (Cockcroft and Gault 1976).
- •Preserved liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN) in the absence of liver metastases; \< 5 x ULN in the case of liver metastases.
Exclusion Criteria
- •Patients with a second active malignant tumor.
- •Patients with tumors treated in the last 2 years.
- •Pregnant or breastfeeding women.
- •Women of child-bearing potential who do not agree to use a contraceptive method during treatment. Women participating in the study should have undergone surgical sterilization, be post-menopausal, or agree to use a highly effective contraceptive method (in accordance with CTFG (clinical trial facilitation group) criteria) during the treatment period. Patients of both sexes and their partners must use effective contraception during treatment and, at least, up to four months after completing treatment. Since oral contraceptives cannot possibly be considered "effective contraceptive methods", they should be used in conjunction with another method, such as a barrier method
- •Fertile men who do not agree to use a contraceptive method during treatment. Male participants in the study should have undergone surgical sterilization, or agree to use a highly effective contraceptive method (in accordance with CTFG (clinical trial facilitation group) criteria) during the treatment period.
- •Patients with gastrointestinal disorders, including:
- •Inability to take oral medication.
- •Need for parenteral nutrition.
- •Prior surgical procedures affecting absorption.
- •Active gastrointestinal bleeding.
Arms & Interventions
Treatment with cabozantinib prior to cytoreductive nephrectomy
To evaluate the efficacy of preoperative cabozantinib treatment as measured by the radiological response rate prior to NC in patients with advanced or metastatic renal cell cancer candidates for NC.
Intervention: Cabozantinib
Outcomes
Primary Outcomes
Radiological response rate prior to cytoreductive nephrectomy
Time Frame: At 12 weeks following the start of the treatment.
Objective response to preoperative treatment with cabozantinib, defined as the percentage of patients that reach complete or partial radiological response after a 12-week cycle of treatment with cabozantinib, defined according to the RECIST 1.1 criteria (Response Evaluation Criteria In Solid Tumors: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD))