Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
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 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.
Inclusion Criteria:
1. Patient must have androgen independent Stage IV prostate cancer, with anaplastic
features as defined by at least one of the following: a) Histologic evidence of small
cell(pure/mixed), locally advanced or metastatic; b) Any of the following at Dx:
exclusive visceral mets, predominant lytic mets, bulky ( >/= 5 cm) lymphadenopathy,
or bulky ( >/= 5 cm) high-grade (Gleason >/= 8) tumor mass in the prostate/pelvis c)
Low PSA at Dx + high volume bone mets.
2. (#1 cont'd) d) Neuroendocrine markers in histology (+ Chromogranin A and/or
Synaptophysin) or serum (abnl high serum Chromogranin A or Bombesin) at Dx or at
progression plus any of the following: elevated serum LDH, malignant HyperCa+, or
elevated serum CEA in the absence of other etiologies. e) Short interval (< 6 months)
to androgen-independent progression following initiation of hormonal therapy with or
without presence of neuroendocrine markers.
3. Patients with small cell carcinoma on histology are not required to have received
prior androgen deprivation therapy (ADT). All other patients must have evidence of
disease progression while on ADT or an unsatisfactory response to >/= 1 month of
castration, as defined by lack of symptom control and/or serum tumor marker response
of < 20% (confirmed by a second value drawn on a different day).
4. Zubrod performance status of
5. Normal EKG or, if EKG is suggestive of cardiomyopathy, patient has a resting Left
Ventricular Ejection Fraction (LEVF) >/= 50% within 4 months.
6. Patient has all of the following pretreatment laboratory data within 14 days before
registration: • Absolute neutrophil count (ANC) >=1,500/mm^3.(unless due to bone
marrow infiltration by tumor, in which case ANC >/= 500/mm^3 are allowed). •
Platelets >=100,000/mm^3 (unless due to bone marrow infiltration by tumor, in which
case platelets >/= 20,000/mm^3 are allowed)
7. (#7 cont'd) • Total bilirubin <= 1.0 mg/dL, • SGPT (ALT) and/or SGOT (AST) >/= 40 (either measured or calculated by Cockcroft formula) • Castrate levels of
serum testosterone ( cell, testosterone > 50ng/mL)
8. Patient has given voluntary written informed consent before performance of any
study-related procedure not part of standard medical care.
Exclusion Criteria:
1. Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of
registration.
2. 2 or more prior chemotherapy regimens (ketoconazole, aminoglutethimide or dutasteride
do not count as chemotherapy for this trial).
3. Prior Platinum, Etoposide, or Taxane-based therapy that was completed less than 6
months from registration.
4. Samarium-153 within four weeks of registration, or Strontium-89 within 12 weeks of
registration. Patients who have received 2 or more doses of bone-seeking
radioisotopes are not eligible.
5. Patient has not recovered from all serious toxic effects of previous chemotherapy,
radiation or antibody therapy, or from previous major surgery.
6. Patients with symptomatic and untreated brain metastases or central nervous system
disease will be excluded. Patients with untreated, asymptomatic brain metastasis (not
requiring corticosteroid treatment for control of CNS symptoms) may be eligible, at
the discretion of the MDACC Principal Investigator. Patients with treated brain
metastases are eligible.
7. Patient with significant atherosclerotic disease, as defined by: a) myocardial
infarction within six months of enrollment. Current uncontrolled/unstable angina
pectoris or electrocardiographic evidence of acute ischemia b) clinically significant
ventricular arrhythmias c) symptomatic congestive heart failure (NYHA Class III)
8. Patient has >= Grade 2 peripheral neuropathy.
9. Patient has renal insufficiency with CrCL < 40ml/min with non-correctable etiologies.
10. Patient has an uncontrolled intercurrent illness (e.g., active infection).
11. Patient has another serious medical or psychiatric illness that could, in the
investigator's opinion, potentially interfere with the patient's ability to provide
informed consent or with the completion of treatment according to this protocol.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate and Time to Progression (TTP)
Outcome Time Frame:
Response evaluated at end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1).
Safety Issue:
Yes
Principal Investigator
Ana M. Aparicio, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2006-0097
NCT ID:
NCT00514540
Start Date:
May 2006
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Anaplastic Prostate Cancer
- Carboplatin
- Docetaxel
- Taxotere
- Paraplatin
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of California-San Francisco | San Francisco, California 94143 |
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
