Tivozanib As Maintenance Therapy In GYN
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.
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Tivozanib as Maintenance Therapy, Post-Chemotherapy, in Patients With Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|
- Progression-Free Survival (PFS) Comparison [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)
- Progression-Free Survival (PFS) Evaluation [ Time Frame: 2 Years ] [ Designated as safety issue: No ]To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.
- Overall Survival (OS) Evaluation [ Time Frame: 2 Years ] [ Designated as safety issue: No ]To evaluate the overall survival with and without maintenance therapy with Tivozanib in patients who have achieved a complete response following therapy for platinum sensitive disease.
- Toxicity Rate Comparison [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]To compare rates of toxicity with and without maintenance therapy with Tivozanib.
- Quality of Life (QOL) Evaluation [ Time Frame: 2 Years ] [ Designated as safety issue: No ]To evaluate the impact of treatment with Tivozanib versus placebo alone on the Quality of Life (QOL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC QLQ-Ovarian Cancer Module (EORTC QLQ-OV28) for functioning and symptoms.
|Study Start Date:||November 2013|
|Study Completion Date:||January 2016|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
No Intervention: Standard Care
Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
Once the participant has signed the consent form, they will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant do not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- Performance status, which evaluates how the participant is able to carry on with their usual activities.
- A tumor assessment by CT (Computerized Tomography) scan or MRI (Magnetic Resonance Imaging.
- Blood tests.
- Urine test.
- Electrocardiogram (ECG)
If these tests show that the participant is eligible to participate in the research study, the participant will begin the study treatment. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
Additional research procedures to be performed during this study:
- Archival tumor testing: During this study, additional tests will be performed on a sample of the participant's original tumor that has been stored in the institution's tissue banks. These tests will be performed on tumor tissue samples from previous biopsies or surgeries for the participant's cancer.
The research done on these samples will involve looking at DNA and proteins in the participant's cancer to see if researchers can learn more about the participant's type of cancer and understand how tivozanib might work on their tumor. Testing of this sample will not require the participant to undergo any additional research procedures.
This research sample collection is a required part of this research study.
Tissue collection / Ownership: Participation in this protocol involves providing specimen(s) of participant's tissue. Please know that if the investigator leaves the institution, the research and the tissue might remain at the DF/HCC or might be transferred to another institution.
After the screening procedures confirm that the participant are eligible to participate in the research study:
If the participant takes part in this research study, the participant will be randomized to receive tivozanib by mouth or no therapy. The participant will be given a study drug diary for each treatment if the participant is randomized to the tivozanib group.
Each treatment cycle lasts 28 days (4 weeks). For participants who are randomized to receive tivozanib, the participant will be taking the study drug once per day for 3 weeks followed by a week of rest. The diary will also include special instructions for taking the study drug. The study drug will be taken once a day with plenty of water.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972516
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Susana Campos, MD, MPH||Dana-Farber Cancer Institute|