Phase 2
Completed N=111
Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Recurrent Fallopian Tube Carcinoma · Ovarian Cancer · Recurrent Primary Peritoneal Carcinoma
Source: ClinicalTrials.gov NCT01716715 ↗
Enrolled (actual)
111
Serious AEs
31.4%
Results posted
Mar 2020
Primary outcomePrimary: Event Free Survival — 3.48; 4.96 months
Summary
This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Free Survival |
3.48; 4.96 | — |
| SECONDARY Number of Participants With Grade 3 or Higher Adverse Events by Type |
2; 4; 4; 0; 15; 2 | — |
| SECONDARY Response, Assessed According to RECIST Version 1.1 |
7.02; 24.07 | — |
| SECONDARY Percentage of Participants With CA125 Response. |
29.4; 58.6 | — |
| SECONDARY Overall Survival |
19.4; NA | — |
| SECONDARY To Estimate the Response Duration Among Patients Who Respond. |
3.8; 7.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
- Patients must have measurable disease or non-measurable (detectable) disease:
- Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray; lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI
- Non-measurable (detectable) disease is defined in this protocol as the absence of measurable disease but at least one of the following conditions:
- Ascites and/or pleural effusion attributed to tumor
- Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
- Patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III or rare tumor protocol for the same patient population; in addition, patients must not be eligible for the currently active phase II cytotoxic protocol in platinum resistant disease
- Patients must have a GOG performance status of 0, 1, or 2
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy to baseline or CTCAE = = 1, collection of 24-hour urine measurement of urine protein is recommended
- Bilirubin less than or equal to 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Albumin greater than or equal to 2.8 g/dL
- Lipase less than or equal to 2 x ULN
- No radiologic or clinical evidence of pancreatitis
- Patients must have a normal baseline thyroid stimulating hormone (TSH); a history of hypothyroidism and/or hyperthyroidism is allowed
- Neuropathy (sensory and motor) less than or equal to grade 1
- Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; sexually active subjects must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug, even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug; pregnant women are excluded from this study
- Patients must have signed an approved informed consent and authorization permitting the release of personal health information
- Patients must meet pre-entry requirements
Exclusion Criteria
- Patients who have had previous treatment with cabozantinib; patients who have received previous treatment with weekly paclitaxel for recurrent or persistent disease
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any porti
Data sourced from ClinicalTrials.gov (NCT01716715). 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. Informational only — not medical advice.