Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT02315430|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Clear Cell Adenocarcinoma Ovarian Clear Cell Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Cabozantinib S-malate Other: Laboratory Biomarker Analysis||Phase 2|
I. To evaluate the anti-tumor activity of cabozantinib (XL184) (cabozantinib-s-malate) in women with persistent or recurrent clear cell ovarian cancer, based on the proportion of patients who survive progression-free for at least 6 months and the proportion who have objective tumor response (complete or partial).
I. To determine the nature, frequency and maximum degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 for cabozantinib (XL184).
II. To determine the progression free survival (PFS) and overall survival (OS) for patients with persistent or recurrent clear cell ovarian cancer treated with cabozantinib (XL184).
I. To examine the expression of phosphatase and tensin homolog gene (PTEN), phosphorylated v-akt murine thymoma viral oncogene homolog 1 (pAKT), cyclin E, and met proto-oncogene (MET) in formalin-fixed, paraffin-embedded tumor.
II. To examine MET amplification (fluorescence in situ hybridization) in tumor specimens and the relationship to response.
Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum|
|Actual Study Start Date :||April 1, 2015|
|Actual Primary Completion Date :||February 9, 2019|
|Actual Study Completion Date :||February 9, 2019|
Experimental: Treatment (cabozantinib-s-malate)
Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis
Optional correlative studies
- Progression-free survival [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months ]A modification of the bivariate two-stage design of Sill, et al, which uses the numbers of patients progression-free at 6 months and the number with objective responses to make inferences about the efficacy of the study drug will be used. Will be characterized graphically and using descriptive statistics such as median survival based on Kaplan-Meier estimates.
- Complete or partial objective tumor response, evaluated using the RECIST v1.1 [ Time Frame: Up to 28 days ]
- Incidence of toxicity as assessed by CTCAE v4 [ Time Frame: Up to 5 years ]The nature, frequency and maximum degree of toxicity will be determined. Events will be tabulated using maximum grade for each adverse event term regardless of attribution to study drug.
- Progression-free survival [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]Will be characterized graphically and using descriptive statistics such as median survival based on Kaplan-Meier estimates.
- Overall survival [ Time Frame: Time from start of treatment to time of death or the date of last contact, assessed up to 5 years ]Will be characterized graphically and using descriptive statistics such as median survival based on Kaplan-Meier estimates.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315430
|Principal Investigator:||John H Farley||NRG Oncology|