Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT01853644 | Completed Phase 2 Results DMC

• 1 other identifier: STU00073756
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Epithelial Ovarian Cancer; Recurrent Fallopian Tube Cancer; Recurrent Primary Peritoneal Cancer

Keywords

Cancer; Recurrent; Ovary; Fallopian Tube; Primary Peritioneal; Phase II; Platinum Resistant

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the number of patients with complete response plus those with partial response as measured by RECIST 1.1 where: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)

Secondary Outcomes (3)

• Progression Free Survival (PFS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib

  Up to 36 months

• Number of Patients Who Experienced Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib

  During treatment and up to 30 days after completion of study treatment. Range of cycles 1-32 (1 cycle =28 days).

• Overall Survival (OS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib

  Up to approximately 42 months

Study Arms (1)

Treatment (Tivozanib)

EXPERIMENTAL

Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy

Drug: Tivozanib

Interventions

Tivozanib DRUG

1.5 mg Given PO (orally)days 1-21 or every 28 day cycle

Also known as: AV-951, Oral VEGF receptor tyrosine kinase inhibitor AV-951

Treatment (Tivozanib)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have recurrent or persistent, platinum resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma; platinum-resistant disease is defined as a recurrence within 6 months of completing adjuvant, platinum-based chemotherapy
• 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 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 in a patient is defined in this protocol as one who does not have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria but does have a cancer antigen 125 (CA-125) greater than or equal to two times the upper normal limit within the last 60 days (confirmatory at baseline) and at least one of the following conditions:
• Ascites and/or pleural effusion attributed to tumor
• Hypermetabolic lesions on positron emission tomography (PET) scan
• Patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
• Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
• Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration
• At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy, thoracotomy, video assisted thorascopic surgery (VATS); there is no restriction on minor procedures (e.g., minor: central venous access catheter placement, ureteral stent placement or exchange, paracentesis, thoracentesis)
• Patients must have had one prior taxane and platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organo platinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic (biologic/targeted agents, such as bevacizumab) or extended therapy administered after surgical or non-surgical assessment; there is no maximum number of prior regimens;
• patients may not have had any prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, investigational or licensed drug that targets vascular endothelial growth factor \[VEGF\] or VEGF receptors/pathway or are mammalian target of rapamycin \[mTOR\] inhibitors) for treatment of recurrent ovarian cancer
• Patients must have signed an approved informed consent and authorization permitting the release of personal health information

You may not qualify if:

• Age \< 18 years
• Patients who have had previous treatment with tivozanib
• Hemoglobin \< 9.0 g/dL
• Absolute neutrophil count (ANC) \< 1500 per mm\^3
• Platelet count \< 100,000 per mm\^3
• Total bilirubin \> 1.5 × upper limit of normal (ULN) (or \> 2.5 x ULN for subjects with asymptomatic Gilbert's syndrome)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 × ULN (or \> 5 × ULN for subjects with liver metastasis)
• BOTH total bilirubin \> ULN AND AST/ALT \> ULN
• Alkaline phosphatase \> 2.5 × ULN (or \> 5 × ULN for subjects with liver or bone metastasis)
• Creatinine \> 2.0 × ULN
• Prothrombin time (PT) such that international normalized ratio (INR) \> 1.5 x ULN (unless a patient is on therapeutic warfarin) or a partial thromboplastin time (PTT) \> 1.5 x ULN
• Proteinuria \> 3+ by urinalysis or urine dipstick
• Significant cardiovascular disease, including:
• Symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram (ECHO) of =\< 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

Sponsors & Collaborators

• Northwestern University: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

CDH-Delnor Health System - Northwestern Medicine Cancer Center

Warrenville, Illinois, 60555, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Neoplasms; Recurrence

Interventions

tivozanib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Daniela Matei
• Organization: Northwestern University

daniela.matei@northwestern.edu

312.472.4684

Study Officials

• Daniela Matei, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniela Matei, MD

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 15, 2013
• Study Start: June 6, 2013
• Primary Completion: October 2, 2018
• Study Completion: May 11, 2021
• Last Updated: October 12, 2021
• Results First Posted: February 28, 2020

Record last verified: 2021-09

Locations

US (2)