Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate

NCT00598858 | Withdrawn Phase 2 DMC

• 3 other identifiers: UCI 07-142007-5904NCI-2012-02085
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot phase II trial studies docetaxel and prednisone in treating patients with newly diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as prednisone, may stimulate the immune system in different ways and stop cancer cells from growing. Giving docetaxel and prednisone together may kill more tumor cells.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer

Keywords

prostate cancer; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• PSA response rate (partial response (PR) + complete response (CR))

  Expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher's exact test. Associations between PSA response and tumor response, and PSA response and gene expression will also be examined by Fisher's exact test.

  9 weeks

Secondary Outcomes (4)

• Rates of tumor response

  Up to 7 days after completion of study treatment

• The rate of negative surgical margin

  Up to 7 days after completion of study treatment

• The proportion of patients with pathological down-staging defined as evidence of decreased pathological stage or Gleason score when compared with pretreatment pathological stage

  Up to 7 days after completion of study treatment

• Adverse events defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment

  Up to 28 days after completion of study treatment

Study Arms (1)

Treatment (docetaxel and prednisone)

EXPERIMENTAL

Patients receive docetaxel IV over 60 minutes on days 1 and 2 and prednisone PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Docetaxel; Drug: Prednisone

Interventions

Docetaxel DRUG

Given IV

Also known as: 114977-28-5, 40466, 628503, RP 56976, RP56976, Taxotere, TXT

Treatment (docetaxel and prednisone)

Prednisone DRUG

Given PO

Also known as: Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta(1)-Cortisone, Delta-Dome, Deltacortene, deltacortisone, deltadehydrocortisone, Deltison, Deltra, Econosone, Liquid Pred, Lisacort, Meprosona-F, metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, PRD, PRED, Predeltin, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisonum, Prednitone, Promifen, Servisone, Sk-Prednisone, Sterapred

Treatment (docetaxel and prednisone)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have a histological diagnosis of adenocarcinoma of the prostate which is measurable or evaluable Stage I or II.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Patient must have a pre-study PSA within 28 days prior to start of therapy.
• Patients who have received prior radiotherapy are not eligible.
• Patient must have an adequate renal function
• Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
• Age \> 18
• Patients must be able to take oral medications

You may not qualify if:

• Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis within 28 days and by a bone scan within 42 days prior to start of therapy.
• Patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
• Patients must not be treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole).
• Patients must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
• Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
• Patients should not have any medical life-threatening complications of their malignancies
• Patients should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV).
• Patients should not have current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
• Patients with history of myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within 6 months
• Patients with clinically significant peripheral vascular disease
• Patients with evidence of bleeding diathesis or coagulopathy
• Patients with central nervous system or brain metastases
• Patients who had major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study

Sponsors & Collaborators

• John P. Fruehauf: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone; deltacortene; prednylidene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• John P. Fruehauf, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. John P. Fruehauf

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 23, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 8, 2016

Record last verified: 2013-04