Phase II Study of Pazopanib and Topotecan in Cervical Cancer

Cervical Cancer Clinical Trial

Official title: A Phase II Study of Pazopanib and Oral Topotecan in Women With Recurrent Cervical Cancer

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to learn if the combination of topotecan and pazopanib can help to control recurrent cervical cancer. The safety of the study drug combination will also be studied.

Clinical Trial Description

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drugs in 28-day study cycles.

You will take pazopanib every day for 28 days. You will take topotecan at about the same time every day on Days 1-21, but not take it on Days 22-28.

You should not take pazopanib 1 hour before or within 2 hours after eating. The pazopanib tablets should be swallowed whole with about a cup (8 ounces) of water.

You should not chew, crush, dissolve, or divide either the topotecan or the pazopanib tablets.

You will be given a study drug diary in which you will write information about when you take the study drug each time and how much you took. You will bring this diary to every study visit.

Study Visits:

On Day 1 of each cycle:

• You will have a physical exam. This will include a pelvic exam every 2 cycles.

• Blood (about 2 tablespoons) and urine will be collected for routine tests.

• Blood (about 2 tablespoons) will be collected for biomarker testing (Cycles 1 and 2 only), including genetic biomarkers. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

• If you can become pregnant, you will have a urine pregnancy test.

If you are taking warfarin, blood (about 2 tablespoons) will be drawn to check your blood's ability to clot. This will be done weekly during Cycle 1 and on any cycle after which you change your dose of warfarin or one of the study drugs.

On Day 1 of every even-numbered cycle (Cycles 2, 4, 6, and so on), you will have a CT scan or MRI of your abdomen and pelvis to check the status of the disease. You will also have an x-ray or CT scan of the chest to check the status of the disease as needed.

If the disease appears to be getting better at any time while you are taking the study drug, blood (about 2 tablespoons) will be drawn for biomarker testing.

If the study doctor thinks you are responding to the study drugs, blood (about 2 tablespoons) will be drawn on Day 1 of Cycle 6. If you leave the study before then, this sample will be drawn at that time.

End-of-Study Visit:

Within 4 weeks after your last dose of study drugs:

• You will have a physical exam.

• Blood (about 2 ½ teaspoons) will be drawn for routine tests.

• You will have a chest x-ray and either a CT scan or an MRI to check the status of disease.

If you are taking warfarin, blood (about 2 tablespoons) will be drawn to check your blood's ability to clot.

° If you stopped taking the study drug before Cycle 6 because the disease got worse, blood (about 2 tablespoons) will be drawn for biomarker testing.

Follow-Up Visits:

If you came off study for a reason other than the disease getting worse, you will be asked to return to the clinic for follow-up testing every 3 months. At these visits:

• You will have a physical exam.

• If the study doctor thinks it is needed, you will have a CT scan, MRI, or x-ray to check the status of the disease.

If the disease did get worse, you will be called every 3 months and asked about how you are doing. Each call should last about 5 minutes.

This is an investigational study. Pazopanib is FDA approved and commercially available for the treatment of advanced kidney cancer and certain types of advanced soft tissue sarcoma such as bone, cartilage, fat, or muscle. Topotecan is FDA approved and commercially available for the treatment of metastatic ovarian cancer that has returned after treatment and for the treatment of small cell lung cancer that has returned after first-line treatment. Topotecan is also FDA approved to treat advanced, recurrent or persistent carcinoma of the cervix in combination with cisplatin. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work.

Up to 40 participants will be enrolled in this multicenter study. Up to 30 will take part at MD Anderson. Up to 10 will be enrolled at the Harris Health System. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

• NCT number: NCT02348398
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2016