Assess efficacy and safety of cabozantinib in monotherapy in advanced/metastatic cervical cancer (CC) after failure of platinum-based regimen treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
Institut de cancérologie de l'Ouest
Angers, France
Centre François Baclesse
Caen, France
Centre Oscar LAMBRET
Lille, France
Centre Léon Bérard
Lyon, France
Efficacy of Cabozantinib: Proportion of Patients With Disease Control Rate
Efficacy assessed by the proportion of patients with disease control rate. Disease Control Rate (DCR) was defined as the proportion of participants who achieved complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to the study-specific tumor response assessment criteria.
Time frame: 3 months after cabozantinib treatment initiation.
Safety of Cabozantinib: Proportion of Patients With Clinical Gastro-intestinal (GI) Perforation/Fistula, GI-vaginal Fistula and Genito-urinary (GU) Fistula Events Grade ≥ 2 (NCI CTCAE v 5.0)
Safety assessed by the proportion of patients with clinical gastro-intestinal (GI) perforation/fistula, GI-vaginal fistula and genito-urinary (GU) fistula events grade ≥ 2 (NCI CTCAE v 5.0)
Time frame: toxicities occurring up to 1 month after the end of treatment
Objective Response (RECIST v1.1 Criteria)
Objective response rate defined as the percentage of patients who have achieved complete response or partial response with RECIST 1.1 criteria.
Time frame: From treatment start up to 24 months
Progression-free Survival (PFS)
Progression-free survival, defined as the time between initiation of cabozantinib treatment and progression (RECIST 1.1 criteria) or death of any cause whichever occurs first.
Time frame: At the end of cycle 3,6,9... (each cycle is 28 days) through study completion, an average of 1 follow-up year
Overall Survival
Overall survival, defined as the time between initiation of cabozantinib treatment and death of whatever cause.
Time frame: through study completion, an average of 1 follow-up year
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Institut de Cancérologie de Montpellier
Montpellier, France
Institut de cancérologie de l'Ouest
Nantes, France
Institut CURIE
Saint-Cloud, France
Institut Gustave Roussy
Villejuif, France
Safety Profile of Cabozantinib
Rate of patients observing at least one toxicity, evaluated according to NCI CTCAE v5.0 criteria. Details will then be given in Adverse Events section.
Time frame: every cycle of treatment (each cycle is 28 days) through study completion, an average of 1 follow-up year
Incidence of Treatment Quality-of-life of Patients Assessed by EORTC QLQ-C30 /CX24 Questionnaire
The EORTC QLQ-C30 is a validated questionnaire used to assess health-related quality of life in cancer patients. It measures global quality of life, functional status, and symptom burden. The EORTC QLQ-CX24 is a cervical cancer-specific module that complements the QLQ-C30 by evaluating disease- and treatment-related symptoms, body image, and sexual functioning. For both questionnaires, raw scores are linearly transformed to a standardized scale ranging from 0 to 100. Higher scores on functional and global quality-of-life scales indicate better functioning and quality of life, whereas higher scores on symptom scales indicate greater symptom severity or more problems. For the QLQ-CX24, higher scores on sexual activity and sexual enjoyment reflect better functioning. In general, high functional scores and low symptom scores indicate a more favorable health-related quality of life.
Time frame: At Day 15 of cycle 2 (each cycle is 28 days)