Preoperative Docetaxel for Localized Progressive Castration-resistant Prostate Cancer (CRPC)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00811031
First received: December 16, 2008
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

Objectives:

Primary:

  • To evaluate the association of the probability of increase in phosphorylation of platelet-derived growth factor receptor (PDGFR) of > 0.5 in peripheral blood leucocytes following pre-operative docetaxel chemotherapy, with progression-free survival in localized castration-resistant prostate cancer (CRPC)

Secondary:

  • To evaluate the association of the probability of increase in phosphorylated platelet-derived growth factor receptor (PDGFR) expression in peripheral blood leucocytes > 0.5 with indices of tumor regression including PSA-decline by 50% and measures of objective regression of tumor by transrectal MRI following pre-operative docetaxel therapy.
  • Explore associations of probability of increase in phosphorylated PDGFR in peripheral blood leucocytes following pre-operative docetaxel therapy with plasma PDGF kinetics and spatial and quantitative PDGF and phosphorylated PDGFR expression in tumor and stromal compartments in resected specimens.
  • Evaluate the association of probability of increase in phosphorylated PDGFR expression in peripheral blood leucocytes following pre-operative docetaxel chemotherapy with overall survival outcomes.
  • Assess global quality of life measures at baseline and 6 and 12 months post-operatively.
  • Create a tissue archive comprising tumor and peripheral blood specimens as a suitable resource for future genomic and proteomic studies.

Condition Intervention Phase
Prostate Cancer
Drug: Taxotere
Drug: Prednisone
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: A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR) [ Time Frame: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model. ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Taxotere + Prednisone Drug: Taxotere
75 mg/m^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.
Other Name: docetaxel
Drug: Prednisone
5 mg twice a day by mouth.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with adenocarcinoma of the prostate (ductal or acinar).
  2. Symptomatic or evidence of progressive disease in the primary tumor by digital rectal examination, cystoscopy and/or radiological imaging without symptomatic or objective evidence of systemic disease progression.
  3. Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
  4. Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If localized progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.
  5. Surgically resectable disease as assessed by the collaborating urological oncologist.
  6. Patients must be >/= 18 years of age.
  7. Patients must have a performance status of </= 2 (ECOG).
  8. Patients must have an expected survival from cancer or co-morbidity of six months.
  9. Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
  10. Patients may not have received docetaxel or other chemotherapeutic agents in the last 6 months or have been defined as docetaxel-resistant or intolerant previously.
  11. Patients must have adequate bone marrow function defined as an Hgb >/= 8.0 g/dl, absolute peripheral granulocyte count of >/= 1,500/mm^3 and platelet count of >/= 100,000/mm^3.
  12. Patients must have adequate hepatic function defined with a bilirubin of </= upper limits of normal. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used (see chart below in Study Plan).
  13. Patients must have adequate renal function defined as creatinine clearance >/= 30 cc/min (measured or calculated by Cockcroft and Gault formula).
  14. Must be fully recovered from any previous surgery, in terms of wound healing.
  15. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
  16. Men with the ability to father a child must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

  1. Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.
  2. Patients with small cell or sarcomatoid variant of prostate cancer.
  3. Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia by symptoms or ECG.
  4. Oxygen-dependent lung disease, > grade 2 peripheral neuropathy, uncontrolled hypertension or uncontrolled diabetes mellitus.
  5. Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder, Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.
  6. Patients who are unwilling to provide blood or tissue specimens required for the primary objectives of the study.
  7. Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.
  8. Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811031

Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi
Investigators
Principal Investigator: Lance Pagliaro, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00811031     History of Changes
Other Study ID Numbers: 2008-0045
Study First Received: December 16, 2008
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate
prostate gland
prostate cancer markers
Taxotere®
Docetaxel
Prednisone
Castration Resistant Prostate Cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 22, 2014