Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
1 other identifier
interventional
121
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started May 2006
Longer than P75 for phase_2 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
September 1, 2020
CompletedSeptember 1, 2020
August 1, 2020
6.9 years
August 9, 2007
April 30, 2014
August 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
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)
Study Arms (1)
First-Line/Second-Line Chemotherapy
EXPERIMENTALFirst-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.
Interventions
75 mg/m\^2 IV over 60 Minutes on Day 1 of 21 day cycle.
AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of registration.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California-San Francisco
San Francisco, California, 94143, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 23649003RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Pruitt, Quality Assurance Specialist
- Organization
- University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ana M. Aparicio, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 10, 2007
Study Start
May 1, 2006
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 1, 2020
Results First Posted
September 1, 2020
Record last verified: 2020-08