Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Carboplatin; Etoposide; Cisplatin
Intervention description: 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.; 120 mg/m^2 daily for 3 days of 21 day cycle.; 25 mg/m^2 for 3 days of 21 day cycle.
Intervention MeSH terms: Carboplatin; Docetaxel; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Anaplastic Prostate Cancer; Carboplatin; Docetaxel; Taxotere; Paraplatin

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.
    

Eligibility criteria:

        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
             prostate-specific antigen (PSA) at diagnosis (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 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.

          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 </= 2.

          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 </= 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)

          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 central nervous system (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 cranial cruciate ligament (CrCL) < 40 ml/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.