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Neoadjuvant Axitinib in Prostate Cancer

2014-08-27 04:00:28 | BioPortfolio

Summary

The goal of this clinical research study is learn if adding axitinib to hormonal therapy can help to control prostate cancer when given before surgery. The safety of this drug will also be studied.

Description

Study Drug:

Axitinib is designed to block the formation of new blood vessels, which are involved in the growth and development of tumors.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of the dice) to 1 of 2 groups:

- If you are in Group A, you will receive axitinib and hormonal therapy.

- If you are in Group B, you will receive hormonal therapy alone.

You will have a 2 out of 3 chance of being placed in Group A. You have a 1 out of 3 chance of being placed in Group B.

Study Drug Administration:

All participants will receive hormonal therapy. The hormonal drug you receive will be standard of care hormone therapy. The study doctor will decide what hormone therapy you will receive and will explain when and how you should take the hormone therapy and any risks.

You will have 8 weeks of hormone therapy before you are assigned to a study group. After you are assigned to a study group, you will receive up to 4 more months of hormone therapy.

If you are in Group A, you will also take 1 capsule of axitinib by mouth 2 times a day. You will be asked to take your blood pressure 2 times a week and record it in a diary before taking your axitinib dose. Note: If your blood pressure is above 150 systolic (the upper number) OR above 100 diastolic (the lower number) or if you develop any symptoms related to increased blood pressure please contact your study doctor immediately. You can take your blood pressure at home or elsewhere, such as at the drug store or doctors office. Doses should be taken about 12 hours apart and at about the same time each day, with food. If you miss a dose, you may take it up to 3 hours late before the next scheduled dose; otherwise do not make up the missed dose. Instead, skip the missed dose and take your next dose as scheduled. If you vomit any time after taking a dose do not make it up, but instead take your next dose as scheduled. You will be asked to keep a diary to help you keep track of when you take each dose of the study drug. Record any missed or vomited doses in the diary. Bring the diary with you to each visit.

Each cycle is 30 days. You should return all unused study drug and/or empty pill bottles at the end of each cycle.

Study Visits:

At every visit, you will be asked about any side effects you have had and any drugs you may be taking.

About 8 weeks after you begin hormonal therapy:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 3-4 teaspoons) will be drawn for routine tests and to check your PSA. Your blood will also be tested for levels of certain proteins.

- You will have an ultrasound-guided biopsy of the prostate with 10-12 samples collected. You will be separately consented for this biopsy, which will describe the procedure and its risks in more detail.

- Blood (about 2 tablespoons) will be drawn for routine tests. Your blood will also be tested to check your thyroid function (Group A only).

- Urine will be collected for routine tests (Group A only).

- You will have an ECG (Group A only).

On Day 15 of Cycle 1 (Group A only):

- Your vital signs and weight will be measured.

- Blood (about 3-4 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 2 and 3 (Group A only):

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 3-4 teaspoons) will be drawn for routine tests to check your PSA and testosterone levels, and to check your thyroid function.

- Urine will be collected for routine tests

About 2 months before surgery (Group B only):

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 2 teaspoons) will be drawn to check your PSA and testosterone levels.

About 2 weeks before surgery or if you go off study early:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- You will have a digital rectal exam.

- Your performance status will be recorded.

- Blood (about 3-4 teaspoons) will be drawn for routine tests and to check your PSA and testosterone levels. Your blood will also be tested for levels of certain proteins.

- You will have a CT scan or MRI scan of the chest, abdomen, and pelvis to check the status of the disease.

- You will have a bone scan to check the status of the disease.

- Blood (about 2 tablespoons) will be drawn for routine tests. Your blood will also be tested to check your thyroid function (Group A only).

Length of Study:

You may receive the study drug(s) for about 8 months. You will be taken off study early if the disease gets worse, if you have intolerable side effects, or if your study doctor thinks it is in your best interest to stop.

Your participation on the study will be over once you have completed the follow-up visits after surgery.

Surgery:

After 8 months of study treatment, you will have surgery to remove your prostate. You will be asked to sign a separate consent form for this surgery, and the risks will be discussed with you.

Long-Term Follow-Up:

At 1 month after your surgery:

- You will be asked about any drugs or treatments you may be receiving (including over-the-counter drugs, herbal remedies, vitamins, and/or supplements).

- You will be asked about any side effects you have had.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 2 teaspoons) will be drawn for PSA and testosterone levels.

- If you are in Group A, blood (about 2 tablespoons) will be drawn for routine tests and to check your thyroid function.

At 3 months after your surgery:

- Your medical history will be recorded.

- You will be asked about any disease-related symptoms and/or side effects you may have had.

- You will have a physical exam, including measurement of your weight, height, and vital signs.

- Your performance status will be recorded.

- Blood (about 3-4 teaspoons) will be drawn for routine tests and to check your PSA and testosterone levels.

You will have follow-up visits every 3 months for the first year, every 4 months for the second year, every 6 months in the third to fifth year, and 1 time a year after that unless the disease worsens, you start taking hormone therapy, or you begin radiation treatments. At these visits, blood (about 3-4 teaspoons) will be drawn for routine tests and to check your PSA and testosterone levels.

This is an investigational study. Axitinib is not FDA approved or commercially available. Axitinib is currently being used for research purposes only.

Up to 54 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

ADT Therapy, Axitinib, Prostatectomy

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:28-0400

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