Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

Completed · Phase 2

Conditions studied: Clear Cell Renal Cell Carcinoma, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7

In brief

This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.

Key facts

Study ID

NCT01835158

Run by

National Cancer Institute (NCI)

People needed

157

Starts

2013-07-08

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Renal cell carcinoma with some component of clear cell histology; histologic documentation of metastatic disease is not required
• Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma (RCC) (equivalent to stage IV RCC, according to American Joint Committee on Cancer [AJCC] staging)
• Eligible patients must be intermediate/poor risk, per the International Metastatic Renal Cell Carcinoma (mRCC) Database Consortium (Heng) criteria; patients must therefore have as one or more of the following six factors:
• Time from diagnosis of RCC to systemic treatment < 1 year
• Note: systemic treatment refers to the initiation of A031203 protocol treatment
• Hemoglobin < the lower limit of normal (LLN)
• Corrected calcium > the upper limit of normal (ULN)
• Karnofsky performance status < 80%
• Neutrophil count > ULN
• Platelet count > ULN
• No radiographic evidence of cavitating pulmonary lesion(s)
• No tumor invading the inferior vena cava (IVC) or superior vena cava (SVC) blood vessels
• No evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days prior to registration
• No prior systemic treatment for RCC; supportive therapies such as bisphosphonates (zoledronic acid) or denosumab are permitted
• Patients must not have had a major surgical procedure or significant traumatic injury within 6 weeks prior to study registration, and must have fully recovered from any such procedure; however, patients who have had a nephrectomy may be enrolled 4 weeks after surgery, providing there are no wound-healing complications; the following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
• Radiation:
• To the brain, thoracic cavity, abdomen, or pelvis must be completed at least 90 days before registration;
• To bone must be completed at least 14 days before registration; and
• To any other sites must be completed at least 28 days before registration In all cases, there must be complete recovery and no ongoing complications from prior radiation therapy
• No chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors; patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
• Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
• No active brain metastases; patients with treated, stable brain metastases for at least three months are eligible as long as they meet the following criteria:
• Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or CT); (stable dose of anticonvulsants are allowed); treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to registration are not eligible
• Baseline brain imaging (MRI/CT) is required
• No serious non-healing wound, ulcer, or bone fracture requiring intervention within 28 days prior to registration

Where it is running

• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Community Cancer Institute — Clovis, California, United States
• University Oncology Associates — Clovis, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• San Diego VA Medical Center — San Diego, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rocky Mountain Cancer Centers-Midtown — Denver, Colorado, United States
• SCL Health Saint Joseph Hospital — Denver, Colorado, United States
• Rocky Mountain Cancer Centers-Rose — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Southern Cancer Center PC-Providence — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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