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A Phase II Study of Docetaxel Plus Carboplatin in Hormone Refractory Prostate Cancer Patients Refractory to Prior Docetaxel-based Chemotherapy

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Study of Docetaxel Plus Carboplatin in Hormone Refractory Prostate Cancer Patients Refractory to Prior Docetaxel-based Chemotherapy

Patients will receive both carboplatin and docetaxel. This treatment is given in the
outpatient department once every 3 weeks (called one cycle).

One day prior to the day of chemotherapy, patients are given a steroid drug (dexamethasone)
to be taken twice a day for 3 days. This helps to decrease the risk of an allergic

On the day of chemotherapy, both docetaxel and carboplatin will be given through a vein over
two to three hours. Docetaxel will be given before carboplatin. In addition, patients
receive zofran, an anti-vomiting agent, to try to prevent nausea and vomiting. Study
participants are also given a prescription for anti-nausea pills to take at home.

After each cycle of treatment, patients are required to get their bloods checked (between
days 8-12 of the cycle). This may be done at an outside laboratory closer to the patient's

Treatment will be repeated every three weeks provided the blood tests and physical
examination done prior to each treatment are acceptable. If a patient is not able to receive
the next scheduled dose of chemotherapy, the doctor will delay the treatment for a week to a
maximum of two weeks, beyond which, the patient will be taken off the trial. If there is a
delay of more than one week or the study participant has significant side effects, their
doctor will decrease the dose of the carboplatin and docetaxel. During the treatment
period, doctors may also prescribe medications to treat low red blood cells or low white
blood cells.

Before each cycle (every 3 weeks), there will be routine blood tests drawn (about 3
teaspoons) to monitor bone marrow, liver, and kidney functions. These samples will look at
two proteins in the blood and may help us predict who will respond to docetaxel and
carboplatin. We will also obtain CT scans after every 3 cycles of treatment and at the end
of the study. A bone scan will also be done after every 3 cycles if there was evidence of
bone involvement on the first bone scan. A bone scan may also be ordered during the study in
patients without prior evidence of bone involvement if the doctor suspects that the cancer
has now spread to the bone.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Evidence of metastatic disease

- Disease progression following androgen deprivation therapy

- Disease progression despite docetaxel-based chemotherapy

- Serum testosterone levels less than 50ng/ml (unless surgically castrated). Patients
must continue androgen deprivation with a luteinizing hormone-releasing hormone
(LHRH) analogue if they have not undergone orchiectomy.

- No use of antiandrogens for at least 4 weeks

- Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2

- Acceptable white blood cell (WBC), platelets, creatinine and AST counts

Exclusion Criteria:

- Significant peripheral neuropathy defined as grade 2 or higher

- Within 4 weeks since completing external beam radiotherapy or 8 weeks since
completing radiopharmaceutical therapy (strontium, samarium)

- Prior platinum-based chemotherapy (cisplatin or carboplatin) for hormone- refractory
prostate cancer

- Concomitant chemotherapy, investigational agents or systemic steroids

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective is to determine the efficacy and safety of docetaxel plus carboplatin as salvage chemotherapy in patients with hormone refractory prostate cancer who have progressed on prior docetaxel-based chemotherapy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mary-Ellen Taplin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2004

Completion Date:

September 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Cancer of the prostate
  • Cancer of prostate
  • Docetaxel
  • Carboplatin
  • Prostatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Lowell General Hospital Lowell, Massachusetts  01854
Oregon Health and Science University Portland, Oregon  97201
Wentworth Douglass Hospital Dover, New Hampshire  03820