Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer

NCT06377722 | Terminated Phase 2

• 1 other identifier: CABOPRE
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

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).

Conditions

Renal Cell Carcinoma Metastatic; Renal Cell Carcinoma Stage IV; Renal Cell Carcinoma Stage III

Outcome Measures

Primary Outcomes (1)

• Radiological response rate prior to cytoreductive nephrectomy

  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))

  At 12 weeks following the start of the treatment.

Study Arms (1)

Treatment with cabozantinib prior to cytoreductive nephrectomy

EXPERIMENTAL

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.

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

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.

Also known as: No other intervention names

Treatment with cabozantinib prior to cytoreductive nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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.
• Lipase \< 2 x ULN. Amylase \< 2 x ULN.
• INR (international normalized ratio) and APTT (activated partial thromboplastin time) ≤ 1.5 x ULN of the site. This only applies to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation with low molecular weight heparins should maintain stable doses.
• Patients with no radiological or clinical evidence of pancreatitis.
• Patients with evaluable tumor disease according to the RECIST criteria 1.1 (Eisenhauer et al. 2009).
• Patients with controlled blood pressure (systolic \< 145 mmHg; diastolic blood pressure \< 90 mmHg).

You may not qualify if:

• 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.
• Malabsorption syndrome.
• Gastrointestinal disorders that increase the risk of perforation.
• Patients with tumors that invade or affect major blood vessels, gastrointestinal tract, or trachea/bronchi.
• Patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases.
• Patients with active hepatitis or hepatitis C.

Sponsors & Collaborators

• Fundacion Oncosur: lead

Study Sites (8)

Institut Català d'Oncologia. Idibell

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Universitario de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Univeristario 12 de Octubre

Madrid, 28041, Spain

Location

Centro Oncológico Clara Campal - HM CIOCC

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Severo Ochoa

Madrid, Spain

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Guillermo de Velasco, MD PhD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: November 1, 2018
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

ES (8)