NCT02315430|CompletedPhase 2ResultsDMC

Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2014-02411NRG-GY001U10CA180868

Study Type

interventional

Target

Locations

1 country

Sites

410

Timeline

RegisteredDec 2014

StartedApr 2015

CompletionFeb 2019

Brief Summary

This phase II trial studies how well cabozantinib-s-malate works in treating patients with ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back or is growing, spreading, or getting worse. Cabozantinib-s-malate may stop the growth of tumor cells by blocking the growth of new blood vessels necessary for tumor growth and also by blocking some of the enzymes needed for cell growth.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach

1 country

410 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

First Submitted

Initial submission to the registry

December 9, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed

4 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 10, 2020

Completed

Last Updated

March 10, 2020

Status Verified

February 1, 2020

Enrollment Period

3.9 years

First QC Date

December 9, 2014

Results QC Date

August 16, 2019

Last Update Submit

February 28, 2020

Conditions

Fallopian Tube Clear Cell Adenocarcinoma Ovarian Clear Cell Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

The Percentage of Patients Who Survive Progression Free for at Least 6 Months
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Every 8 weeks during treatment, assessesd up to 6 months for progression free survival.
Objective Tumor Response
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Every 8 weeks during treatment;assessed up to 20 months.

Secondary Outcomes (3)

Number of Participants With Grade 3 or Higher Adverse Events
Every cycle while on treatment, up to 30 days after treatment ends, an average of 14 months.
Progression-free Survival
Tumor scan done every 8 weeks during treatment, Average progression free survival was 3.6 months.
Overall Survival
Every cycle during treatment, up to 20.1 months.

Study Arms (1)

Treatment (cabozantinib-s-malate)

EXPERIMENTAL

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-malateOther: Laboratory Biomarker Analysis

Interventions

Cabozantinib S-malateDRUG

Given PO

Also known as: BMS-907351, Cabometyx, Cometriq, XL184

Treatment (cabozantinib-s-malate)

Laboratory Biomarker AnalysisOTHER

Optional correlative studies

Treatment (cabozantinib-s-malate)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

A retrospective review of all patients entered will be performed to confirm clear cell histology; patients must have recurrent or, progressive clear cell ovarian cancer not solely based on cancer antigen (CA)-125; primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology; recurrence should be biopsy proven unless the tumor is located in an area deemed unsafe to biopsy by the surgeon; if a biopsy can be obtained without significant risk, then biopsy should be obtained
If the primary tumor had at least 50% clear cell histomorphology, a biopsy of the recurrent or persistent tumor is not required; the percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report; if slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), biopsy of recurrent or persistent disease is required
If slides of the primary tumor are not available for review, a biopsy of the recurrent or persistent tumor is required to confirm at least 50% clear cell histomorphology; the percentage of involvement must be documented in the pathology report or in an addendum to the original report
All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
All patients must submit unstained slides of primary or recurrent tumor for translational analysis
Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1
Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease; platinum sensitive and resistant patients are eligible
Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
Concomitant use of additional anti-neoplastic agents will not be allowed in this study
Patients may not have received previous therapy with a MET inhibitor
Patients must not be eligible for a higher priority (e.g.; phase II/III), National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) protocol for the same population if one exists
Patients must be recovered from effects of recent surgery (28 days must elapse between surgery and the start of treatment with cabozantinib)
Patients must have \>= 4 weeks since prior chemotherapy or radiation (\>= 6 weeks for nitrosoureas or mitomycin C)
Appropriate stage for study entry based on the following diagnostic workup:
History/physical examination within 28 days prior to registration
+18 more criteria

You may not qualify if:

Human immunodeficiency virus (HIV) positive patients
Patients with serious non-healing wound, ulcer, or bone fracture
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=\< 81 mg/day), low-dose warfarin (=\< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study
Patients with clinically significant cardiovascular disease; this includes:
Poorly controlled hypertension (\> 140 mm Hg and \> 90 mm Hg for systolic and diastolic blood pressure \[BP\]) are ineligible
Myocardial infarction or unstable angina within 6 months prior to registration; New York Heart Association (NYHA) grade II or greater congestive heart failure
Cardiac arrhythmia requiring medication
Grade II or greater peripheral vascular disease based on National Cancer Institute (NCI) Common Toxicity Criteria (CTC); e.g. ischemic rest pain, minor tissue loss, and ulceration or gangrene
Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible; patients with a history of hypothyroidism are eligible provided they are currently euthyroid
Patients who have a major surgical procedure, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
Patients must not be eligible for a higher priority NRG clear cell protocol (Gynecologic Oncology Group \[GOG\]-0283); rare patients ineligible for GOG-0283 may be eligible for this trial without prior treatment on dasatinib therapy (e.g. they have been deemed allergic to dasatinib)
Patients who cannot swallow pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead
NRG Oncologycollaborator

Study Sites (410)

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC