A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer
NCT ID: NCT00134706
Last Updated: 2009-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2004-01-31
2009-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Beth Israel Deaconess Medical Center
OTHER
Lowell General Hospital
OTHER
Massachusetts General Hospital
OTHER
Oregon Health and Science University
OTHER
Wentworth-Douglass Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Dana-Farber Cancer Institute
Principal Investigators
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Mary-Ellen Taplin, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Wentworth Douglass Hospital
Dover, New Hampshire, United States
Oregon Health and Science University
Portland, Oregon, United States
Countries
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Other Identifiers
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03-319
Identifier Type: -
Identifier Source: org_study_id