Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)

Kidney Cancer Clinical Trial

Official title: A Phase II Clinical Trial Examining the Impact Of Neoadjuvant Axitinib On Primary Tumor Response In Patients With Locally Advanced Clear Cell Renal Cell Carcinoma

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if axitinib can help to control kidney cancer. The safety of this drug will also be studied.

Clinical Trial Description

The Study Drug:

Axitinib is designed to decrease blood supply to the tumor, which may slow tumor growth.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take axitinib by mouth 2 times a day every day for 12 weeks. The dose may be changed based on any side effects you may have. You should take the drug about 12 hours apart. You should take the pills at about the same time each day. If you vomit anytime after taking a dose, you must not "make it up" with an extra dose, but instead take the next dose as previously scheduled. Any missed dose may be taken late up to 3 hours before the next scheduled dose, otherwise, it should be skipped.

A blood pressure monitor will be given to each participant for home use. You will be given instructions and shown how to monitor your blood pressure.

You will be provided with a calendar to record the date and time of each dose, and your blood pressure reading before taking the drug. Missed doses should also be recorded. You must also bring the study drug bottle to each study visit so the research nurse can count any remaining pills.

A drug list will be given to you to record drugs taken within 4 weeks before you enrolled on the study and while on study. A new list will be provided during each clinic visit. You should not start a new prescription or over-the-counter drug before talking with the study doctor, except in the case of a medical emergency.

Study Visits:

At Week 1:

• You will be asked about any drugs you may be taking.

• Your performance status will be recorded.

• You will complete the questionnaire about kidney cancer care. This questionnaire will take about 5 minutes to complete.

• Women who are able to become pregnant will have a blood (about 1 teaspoon) or urine pregnancy test.

At Week 3:

• Your medical history will be recorded.

• You will have a physical exam.

• Your performance status will be recorded.

• You will have an ECG.

• Blood (about 2 tablespoons) will be drawn for routine testing to check your thyroid function.

• Urine (about 2 tablespoons) will be collected for routine testing.

• You will complete the questionnaire about kidney cancer care.

At Weeks 5 and 9, you will be called and asked if you have had any side effects. This call should take about 10 minutes.

At Weeks 7 and 12:

• Your medical history will be recorded.

• You will have a physical exam.

• Your performance status will be recorded.

• Blood (about 2 tablespoons) will be drawn for routine testing and to check your thyroid function.

• Urine (about 2 tablespoons) will be collected for routine testing.

• You will complete the questionnaire about kidney cancer care.

• You will have a CT scan of chest and abdomen to check the status of the disease.

• At Week 12 only, you will have an ECG.

At Week 13, you will have surgery to remove the kidney tumor. You will receive a separate consent form for this surgery.

At Week 19:

• Your medical history will be recorded.

• You will have a physical exam.

• Your performance status will be recorded.

• Blood (about 2 tablespoons) will be drawn for routine testing and to check your thyroid function.

• You will complete the questionnaire about kidney cancer care.

• You will have a CT scan of chest and abdomen to check the status of the disease.

• If you have been treated for high blood pressure while taking the drug, your blood pressure will be monitored and your blood pressure medication will be reduced. Once your blood pressure reaches a certain level, this will be managed by your primary care doctor.

After Week 19, every 4 months (+/- 2 weeks) for the first 1 year, every 6 months (+/- 2 weeks) for the third and fourth year, then every year (+/- 1 month) for a total of 5 years post surgery:

• Your medical history will be recorded.

• You will have a physical exam.

• Your performance status will be recorded.

• You will have a CT scan of the chest and abdomen to check the status of the disease.

• Blood (about 2 tablespoons) will be drawn for routine testing and to check your thyroid function.

• You will complete the questionnaire about kidney cancer care (only during the first 2 years).

Length of Study:

You will take axitinib for up to 12 weeks. You will stop taking axitinib earlier than expected if the disease gets worse or if you have severe side effects. In both cases, you will move on to surgery after axitinib has been stopped.

After surgery, you will be contacted by the study staff every 4 months (+/- 2 weeks) for 1 year, every 6 months (+/- 2 weeks) for the next 2 years and every 12 months (+/- 1 month) for 2 more years (for a total of 5 years after surgery).

This is an investigational study. Axitinib is FDA approved and commercially available to treat advanced kidney cancer in adults when 1 previous drug treatment for this disease has not worked. In this study, it is being used for research purposes.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

• NCT number: NCT01263769
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: February 2011
• Completion date: June 5, 2023