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Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00514540
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Carboplatin Drug: Etoposide Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
Study Start Date : May 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: First-Line/Second-Line Chemotherapy

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.

Drug: Docetaxel
75 mg/m^2 IV over 60 Minutes on Day 1 of 21 day cycle.
Other Name: Taxotere

Drug: Carboplatin
AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle.
Other Name: Paraplatin

Drug: Etoposide
120 mg/m^2 daily for 3 days of 21 day cycle.

Drug: Cisplatin
25 mg/m^2 for 3 days of 21 day cycle.




Primary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514540


Locations
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United States, California
University of California-San Francisco
San Francisco, California, United States, 94143
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Ana M. Aparicio, MD M.D. Anderson Cancer Center
Additional Information:
Publications of Results:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00514540    
Other Study ID Numbers: 2006-0097
First Posted: August 10, 2007    Key Record Dates
Results First Posted: September 1, 2020
Last Update Posted: September 1, 2020
Last Verified: August 2020
Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Anaplastic Prostate Cancer
Carboplatin
Docetaxel
Taxotere
Paraplatin
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Carboplatin
Docetaxel
Etoposide
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors