Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00514540
First received: August 9, 2007
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

The goal of this clinical research study is to learn about how effective 2 different schedules of chemotherapy drugs (Paraplatin [carboplatin] plus Taxotere [docetaxel] and VePesid [etoposide] plus Platinol-AQ [cisplatin]) are in the treatment of patients with anaplastic prostate cancer. The safety of both therapy combinations will also be studied.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Response evaluated at 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). ] [ Designated as safety issue: No ]
    Response evaluated at 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 Evaluation Criteria in Solid Tumors (RECIST): Complete Response: disappearance of all target lesions. Partial Response: > 30% decrease in sum longest diameter of target lesions, reference baseline sum longest diameter; Progressive Disease: >20% increase in sum of longest diameter target lesions, reference smallest sum longest diameter recorded since treatment started or appearance of 1/> new lesions. Stable Disease: Insufficient shrinkage to qualify as partial response, or insufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.

  • Median Overall Survival [ Time Frame: Baseline (start of treatment) to disease progression or death for any reason, up to 5 years of follow up. ] [ Designated as safety issue: No ]
    From the date of treatment to the date of death and to the date of last follow-up for those still alive. Survival updates taken at 6 month intervals from the offstudy date.


Enrollment: 121
Study Start Date: May 2006
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboplatin + Docetaxel
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.
Drug: Docetaxel
75 mg/m^2 IV Over 60 Minutes On Day 1 Repeat Every 3 Weeks.
Other Name: Taxotere
Drug: Carboplatin
AUC = 5 IV Over 30 Minutes On Day 1 repeat every 3 weeks.
Other Name: Paraplatin

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 PSA at 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 LDH, malignant HyperCa+, or elevated serum 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, • SGPT (ALT) and/or SGOT (AST) </= 4 x the 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 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 CrCL < 40ml/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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00514540

Locations
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
Principal Investigator: Ana M. Aparicio, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00514540     History of Changes
Other Study ID Numbers: 2006-0097
Study First Received: August 9, 2007
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Anaplastic Prostate Cancer
Carboplatin
Docetaxel
Taxotere
Paraplatin

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014