Phase 2
N=13
Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Clear Cell Adenocarcinoma · Ovarian Clear Cell Adenocarcinoma · Recurrent Fallopian Tube Carcinoma · Recurrent Ovarian Carcinoma · Recurrent Primary Peritoneal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02315430 ↗Enrolled (actual)
13
Serious AEs
46.2%
Results posted
Mar 2020
Primary outcome: Primary: The Percentage of Patients Who Survive Progression Free for at Least 6 Months — 23 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cabozantinib S-malate (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Who Survive Progression Free for at Least 6 Months |
23 | — |
| PRIMARY Objective Tumor Response |
— | — |
| SECONDARY Number of Participants With Grade 3 or Higher Adverse Events |
3; 3; 3; 2; 2; 2 | — |
| SECONDARY Progression-free Survival |
3.6 | — |
| SECONDARY Overall Survival |
8.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- The trial is open only to women with recurrent, progressive clear cell carcinoma of the ovary
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky >= 60%) within 28 days prior to registration
- Absolute neutrophil count (ANC) >= 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
- Leukocytes >= 3,000/mcL
- Hemoglobin >= 9 g/dL
- Serum albumin >= 2.8 g/dL
- Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.3 x upper limit of normal (ULN)
- Partial thromboplastin time (PTT) less than or equal to 1.3 x ULN
- Creatinine less than or equal to 1.5 times the ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- The urine protein: creatinine ratio (UPCR) is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR = 12 consecutive months; note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or a
Data sourced from ClinicalTrials.gov (NCT02315430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.