Clinical trial NCT00514540
Conditions: Prostate Cancer
Keywords: Prostate Cancer Anaplastic Prostate Cancer Carboplatin Docetaxel Taxotere Paraplatin
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-05-01; Completion date: 2013-04-01
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn about how effective 2 chemotherapy drugs carboplatin (Paraplatin) plus docetaxel (Taxotere) in the treatment of patients with anaplastic prostate cancer. Patients who continue to have advanced disease will be switched to etoposide (VePesid) plus cisplatin (Platinol-AQ) to study how effective this second line of chemotherapy is in the treatment of patients iwth anaplastic prostate cancer.

The side effects, characteristics of patients who respond, and overall survival will also be studied.

Detailed description:
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division.

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.

Etoposide is a drug that has been shown to interfere with the growth of cancer cells, which may cause them to eventually die.

Cisplatin has an atom at its center that contains platinum. The platinum is supposed to poison the cancer cells, which may cause them to eventually die.

If you are found to be eligible to take part in this study, you will receive carboplatin plus docetaxel by a vein or central line in a vein. You will receive carboplatin over about 30 minutes and docetaxel over about 60 minutes. You will receive this therapy combination on Day 1 of each cycle of therapy (every 3-4 weeks), depending on the recovery of your bone marrow. These 3-4 weeks are considered 1 cycle of therapy. This therapy combination will be given on an outpatient basis. If you experience any side effects, your dose of docetaxel plus carboplatin may be decreased.

You will be given dexamethasone, by a vein in your arm, by central line in a vein, or by mouth, before your therapy begins with docetaxel plus carboplatin. Dexamethasone will help decrease bone marrow inflammation. You will also be given a colony stimulating factor (when the doctor thinks it is needed) to help maintain your white blood cell count to help decrease any chance of infection. Colony stimulating factor will be given as a subcutaneous injection (under the skin), at the discretion of the treating physician, during therapy.

You will have about 2-3 tablespoons of blood drawn at the beginning of each cycle of therapy for routine blood tests and blood tests for cancer markers. You will be asked about any medications you are currently taking.

At the end of the first 2 cycles of therapy, you will have some or all of the scans (performed during the screening visit) repeated to evaluate your disease. If your disease is responding well to the therapy, you will continue on docetaxel plus carboplatin for 2 more cycles. In this case, you will continue receive the study combination until your doctor thinks you have received the most benefit. You will then be followed with some or all of the scans (performed during the screening visit) every 2 months unless your cancer progresses (gets worse) or until you begin on a new therapy after your treatment has ended on this study.

If you are already taking hormone therapy with an luteinizing hormone-releasing hormone (LHRH) agonist (such as Lupron or Zoladex) , you will continue taking these medications. If you are taking an anti-androgen drug (such as Casodex), you should stop taking it.

If your cancer is progressing after having had a maximal response, if your disease does not respond after 2 courses of therapy, or if you are not able to tolerate some side effects of docetaxel plus carboplatin, your chemotherapy will be switched to etoposide plus cisplatin. If this is the case, etoposide plus cisplatin will be given to you by a vein in your arm or central line in a vein. You will receive this therapy combination once a day (etoposide over 60 minutes and cisplatin over 2 hours) for the first 3 days during each cycle of therapy, and then therapy will be repeated every 3 to 4 weeks.

Therapy with etoposide plus cisplatin will be continued as long as your cancer responds well to this therapy and you are not experiencing any intolerable side effects. If you experience any side effects, your dose of etoposide plus cisplatin may be decreased. This treatment combination may be given on an inpatient basis.

You will be removed from this study if your disease gets worse or you experience any intolerable side effects.

If you come off this study because you completed therapy, your disease got worse, or you experienced intolerable side effects, you will have an end-of-study visit. During this visit, you will have blood drawn (about 3 tablespoons) for routine tests. You will have a complete physical exam, including measurement of your vital signs. You will also have your complete medical history recorded and you will be asked about any medications you are currently taking. You will have imaging scans to evaluate your disease (similar to those at screening) if they have not been done in the last 28 days.

Once you are no longer on this study, the research staff will periodically check up on you (about every 6 months). This update will consist of a phone call, an e-mail, or a review of your medical and/or other records. No clinic visits or additional diagnostic studies are required by the study. If contacted by phone, the call would only last a few minutes.

This is an investigational study. Carboplatin, docetaxel, etoposide, and cisplatin are all commercially available and approved by the FDA. Up to 120 patients will take part in this multicenter study. Up to 90 will be enrolled at MD Anderson.

Arms: arm 1: First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m\^2 IV over 60 minutes, Day 1. Repeated every 3 weeks.

Second-Line (EP) Chemotherapy: Etoposide 120 mg/m\^2 daily for 3 days and Cisplatin 25 mg/m\^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
Interventions: intervention 1: Docetaxel intervention 2: Carboplatin intervention 3: Etoposide intervention 4: Cisplatin
Intervention descriptions: intervention 1: 75 mg/m\^2 IV over 60 Minutes on Day 1 of 21 day cycle. intervention 2: AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle. intervention 3: 120 mg/m\^2 daily for 3 days of 21 day cycle. intervention 4: 25 mg/m\^2 for 3 days of 21 day cycle.

Protocol documents: