Prostate CancerPhase 2NCT00514540
Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
A Phase 2 study testing Docetaxel, Carboplatin and Etoposide in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Docetaxel, Carboplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 prostate-specific antigen (PSA) at diagnosis (Dx) + high volume bone mets.
- (#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 lactate dehydrogenase (LDH), malignant HyperCa+, or elevated serum Carcinoembryonic Antigen (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.
- 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).
- Zubrod performance status of </= 2.
- Normal EKG or, if EKG is suggestive of cardiomyopathy, patient has a resting Left Ventricular Ejection Fraction (LEVF) >/= 50% within 4 months.
- 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 cont'd) • Total bilirubin </= 2 mg/dl; if greater, conjugated bilirubin should be <= 1.0 mg/dL, • serum glutamate pyruvate transaminase (SGPT) (ALT) and/or serum glutamate oxaloacetate transaminase (SGOT) (AST) </= 4 times the upper limit of normal (ULN). • Creatinine clearance >/= 40 (either measured or calculated by Cockcroft formula) • Castrate levels of serum testosterone (</= 50ng/mL) if no small cell elements on histology. (If small cell, testosterone > 50ng/mL)
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of standard medical care.
Who cannot join
- Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of registration.
- 2 or more prior chemotherapy regimens (ketoconazole, aminoglutethimide or dutasteride do not count as chemotherapy for this trial).
- Prior Platinum, Etoposide, or Taxane-based therapy that was completed less than 6 months from registration.
- 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.
- Patient has not recovered from all serious toxic effects of previous chemotherapy, radiation or antibody therapy, or from previous major surgery.
- 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 central nervous system (CNS) symptoms) may be eligible, at the discretion of the MDACC Principal Investigator. Patients with treated brain metastases are eligible.
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- 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)
- Patient has >= Grade 2 peripheral neuropathy.
- Patient has renal insufficiency with cranial cruciate ligament (CrCL) < 40 ml/min with non-correctable etiologies.
- Patient has an uncontrolled intercurrent illness (e.g., active infection).
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT MD Anderson Cancer Center
Houston, Texas, 77030
University of California-San Francisco
San Francisco, California, 94143
About this study
Official title: Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel, Carboplatin, Etoposide, Cisplatin
- Keywords
- Prostate Cancer, Anaplastic Prostate Cancer, Carboplatin, Docetaxel, Taxotere, Paraplatin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
75 mg/m^2 IV over 60 Minutes on Day 1 of 21 day cycle.
CarboplatinDrug
Also called Paraplatin
AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle.
EtoposideDrug
120 mg/m^2 daily for 3 days of 21 day cycle.
CisplatinDrug
25 mg/m^2 for 3 days of 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| First-Line/Second-Line Chemotherapy | Experimental | 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. Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Progression (TTP)
TTP defined as time of registration on study till disease progression. Disease status evaluated at the 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).
Measured: Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years.
Response Rate of Salvage Chemotherapy With Etoposide Plus Cisplatin Following Treatment With Docetaxel Plus Carboplatin.
Response rate is the number of participants with response compared to total. Response defined as the absence of disease progression compared to the participant's baseline evaluation, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death.
Measured: Evaluated at the 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startMay 2006
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana M. Aparicio, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514540
- Sponsor's protocol ID
- 2006-0097
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2007
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Aparicio AM, Harzstark AL, Corn PG, Wen S, Araujo JC, Tu SM, Pagliaro LC, Kim J, Millikan RE, Ryan C, Tannir NM, Zurita AJ, Mathew P, Arap W, Troncoso P, Thall PF, Logothetis CJ. Platinum-based chemotherapy for variant castrate-resistant prostate cancer. Clin Cancer Res. 2013 Jul 1;19(13):3621-30. doi: 10.1158/1078-0432.CCR-12-3791. Epub 2013 May 6.
PubMed 23649003
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT00514540
- Acronym / sponsor ID
- 2006-0097
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Anaplastic Prostate Cancer, Carboplatin, Docetaxel, Taxotere, Paraplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Posted 1 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-Line/Second-Line Chemotherapy | Experimental | Drug: Docetaxel, Drug: Carboplatin, Drug: Etoposide, Drug: CisplatinFirst-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 prostate-specific antigen (PSA) at diagnosis (Dx) + high volume bone mets.
- (#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 lactate dehydrogenase (LDH), malignant HyperCa+, or elevated serum Carcinoembryonic Antigen (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.
- 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).
- Zubrod performance status of </= 2.
- Normal EKG or, if EKG is suggestive of cardiomyopathy, patient has a resting Left Ventricular Ejection Fraction (LEVF) >/= 50% within 4 months.
Key exclusion criteria (11 listed)
- Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of registration.
- 2 or more prior chemotherapy regimens (ketoconazole, aminoglutethimide or dutasteride do not count as chemotherapy for this trial).
- Prior Platinum, Etoposide, or Taxane-based therapy that was completed less than 6 months from registration.
- 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.
- Patient has not recovered from all serious toxic effects of previous chemotherapy, radiation or antibody therapy, or from previous major surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere75 mg/m^2 IV over 60 Minutes on Day 1 of 21 day cycle. | Drug | First-Line/Second-Line Chemotherapy |
| CarboplatinAlso: ParaplatinAUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle. | Drug | First-Line/Second-Line Chemotherapy |
| Etoposide120 mg/m^2 daily for 3 days of 21 day cycle. | Drug | First-Line/Second-Line Chemotherapy |
| Cisplatin25 mg/m^2 for 3 days of 21 day cycle. | Drug | First-Line/Second-Line Chemotherapy |
Primary outcome
Median Time to Progression (TTP)
Time frame: Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years.
TTP defined as time of registration on study till disease progression. Disease status evaluated at the 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).
Response Rate of Salvage Chemotherapy With Etoposide Plus Cisplatin Following Treatment With Docetaxel Plus Carboplatin.
Time frame: Evaluated at the 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)
Response rate is the number of participants with response compared to total. Response defined as the absence of disease progression compared to the participant's baseline evaluation, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23649003Aparicio AM, Harzstark AL, Corn PG, Wen S, Araujo JC, Tu SM, Pagliaro LC, Kim J, Millikan RE, Ryan C, Tannir NM, Zurita AJ, Mathew P, Arap W, Troncoso P, Thall PF, Logothetis CJ. Platinum-based chemotherapy for variant castrate-resistant prostate cancer. Clin Cancer Res. 2013 Jul 1;19(13):3621-30. doi: 10.1158/1078-0432.CCR-12-3791. Epub 2013 May 6.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M. Aparicio, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Carboplatin and Etoposide in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time to Progression (TTP) (time frame: Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.