A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Beth Israel Deaconess Medical Center
Lowell General Hospital
Massachusetts General Hospital
Oregon Health and Science University
Wentworth-Douglass Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00134706
First received: August 24, 2005
Last updated: December 7, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to look at the effects (good and bad) of the combination of docetaxel and carboplatin for patients who have progressive prostate cancer after chemotherapy with drugs such as docetaxel. The investigators are also studying whether the measurement of two proteins in the blood may predict who will respond to the combination of docetaxel and carboplatin.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel Plus Carboplatin in Hormone Refractory Prostate Cancer Patients Refractory to Prior Docetaxel-based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary objective is to correlate the clinical and prostate-specific antigen (PSA) response with baseline serum chromogranin A (CGA) and neuron-specific enolase (NSE) levels. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2004
Study Completion Date: September 2009
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel
    Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.
    Drug: Carboplatin
    Given intravenously over 2-3 hours once every three weeks. Participant can continue to receive treatment as long as there is no disease progression or serious side effects.
Detailed Description:

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 reaction.

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 home.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134706

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, New Hampshire
Wentworth Douglass Hospital
Dover, New Hampshire, United States, 03820
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Dana-Farber Cancer Institute
Bristol-Myers Squibb
Beth Israel Deaconess Medical Center
Lowell General Hospital
Massachusetts General Hospital
Oregon Health and Science University
Wentworth-Douglass Hospital
Investigators
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00134706     History of Changes
Other Study ID Numbers: 03-319
Study First Received: August 24, 2005
Last Updated: December 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Prostate Cancer
Cancer of the prostate
Cancer of prostate
Docetaxel
Carboplatin

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014