Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer (NCT00514540) | Clinical Trial Compass
CompletedPhase 2
Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
United States121 participantsStarted 2006-05
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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)
What they're measuring
1
Median Time to Progression (TTP)
Timeframe: 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.
2
Response Rate of Salvage Chemotherapy With Etoposide Plus Cisplatin Following Treatment With Docetaxel Plus Carboplatin.
Timeframe: 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)
✓. Patient has given voluntary written informed consent before performance of any study-related procedure not part of standard medical care.
Exclusion criteria
✕. 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.
✕. 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)