Tivozanib As Maintenance Therapy In GYN

Status: Recruiting
Phase: Phase 2
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01972516 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-375


This research study is evaluating a drug called tivozanib as a possible treatment for ovarian, fallopian tube or primary peritoneal cancer. Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood supply so that it does not get the blood and nutrients it needs to grow. In this research study, the Investigators are looking to see whether tivozanib works as a maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in participants who have achieved a complete response following chemotherapy. Maintenance therapy is given after a disease has responded to previous treatment. It is given to help prevent the spread or recurrence of the tumor.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Susana Campos, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

Inclusion Criteria: - Patients must have no evidence of disease on CT/MRI following treatment for recurrent ovarian, fallopian tube, or peritoneal cancer. Histological confirmation of the original primary tumor is required. - Patient must have high grade papillary serous carcinoma of the ovary, fallopian tube or peritoneum. - Patients must have a CA-125 within normal range. - Age must be greater than or equal to 18 years of age. Because no dosing or adverse event data are currently available on the use of Tivozanib in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials. - Patients may have had up to 1 prior line of therapy (cytotoxic therapy only) in the recurrent setting. Bevacizumab in the upfront setting is allowed, however Bevacizumab or other VEGF pathway targeted therapy in the recurrent setting is not allowed. Hormonal therapy does not count as a prior line. - Recovered from effects of recent surgery, radiotherapy, and chemotherapy. - ECOG performance status ≤2 (see Appendix A). - Participants must have normal organ and marrow function as defined below: - Absolute neutrophil count ≥1,250/mcL - Platelets ≥100,000/mcL - Bilirubin ≤ 1.5 x ULN - AST (SGOT) / ALT (SGPT) ≤ 2.5 x institutional upper limit of normal Alkaline phosphatase ≤ to 2.5 x ULN - Creatinine ≤ 1.5 x institutional upper limit - Less than or equal to 1+ proteinuria on two consecutive dipsticks taken no less than 1 week apart, or < 1 gm protein on 24-hour urine collection or a urine protein:creatinine ratio of < 1. - INR < 1.5; if on anticoagulation: INR is required to be between 2 and 3. Patient must receive one of the three regimens for their platinum sensitive disease: Number of cycles should not have exceeded 8 cycles of 1 regimen in the recurrent setting. - Platinum (Carboplatin or Cisplatin) and Taxane (Paclitaxel or Docetaxel) Carboplatin and Gemcitabine - Carboplatin and Liposomal Doxorubicin - A female is eligible to participate if she is of non-childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment. Sexually active pre-menopausal female subjects (and male subjects whose sexual partners are of childbearing potential) must agree to use adequate, highly effective contraceptive measures, while on study and for 45 days after the last dose of last study drug. Effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable or injectable contraceptives plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. - Prior therapy with bevacizumab or other VEGF pathway targeted therapy in the recurrent setting. Bevacizumab in the upfront setting is allowed. - Participants may not be receiving any other study agents. - Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible. Subjects with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible. Subjects with any other concomitant or prior malignancies are ineligible. - Serious non-healing wounds or ulcers at the time of registration. - History of abdominal fistula or gastrointestinal perforation. - Active bleeding. - Clinically significant cardiovascular disease. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to Tivozanib. - Symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram (ECHO) ≤ 50 % lower limit of institutional normal (LLN). - Uncontrolled hypertension: systolic blood pressure of >140 mmHg or diastolic blood pressure of >90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart. - Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug. - History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation). - Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication). - Coronary or peripheral artery bypass graft within 6 months of screening. - History of Class III or IV congestive heart failure, as defined by the New York Heart Association. - Central nervous system metastases. Note: Subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable without steroid treatment for at least 3 months following prior treatment may be enrolled.
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