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

Prostate Cancer Clinical Trial

— 2007-5904  

Official title:

Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00598858
• Other study ID #: UCI 07-14
• Secondary ID: 2007-5904NCI-201
• Status: Withdrawn
• Phase: Phase 2
• First received: January 10, 2008
• Last updated: December 6, 2016
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2013
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. To determine the rate of a 3-month prostate-specific antigen (PSA) decline of at least 30% by chemotherapy regimen of docetaxel and prednisone in patients with stage I/II prostate cancer, who are scheduled for prostatectomy.

II. To compare tumor, pathological and PSA responses to neoadjuvant docetaxel between patients with intermediate and high grades of prostate cancer.

III. To obtain prostate specimens for genomic correlates with responses of the chemotherapy regimen of docetaxel and prednisone.

OUTLINE:

Patients receive docetaxel intravenously (IV) over 60 minutes on days 1 and 2 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy within 3 weeks after completion of chemotherapy.

After completion of study treatment, patients are followed up within 7 days.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Patients with minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0

• Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess

• Patients with serious, non-healing wound, ulcer, or bone

• Patients who are diagnosed of any other malignancy except non-melanomatous skin cancer in the past 5 years

• Patients receiving anticoagulation therapy (e.g. Coumadin) prior to registration

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer
• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage II Prostate Cancer

Intervention

Drug:
• Docetaxel
Given IV
• Prednisone
Given PO

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
John P. Fruehauf	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rates of tumor response	Expressed with two-sided exact binomial confidence intervals.	Up to 7 days after completion of study treatment	No
Secondary	The rate of negative surgical margin		Up to 7 days after completion of study treatment	No
Secondary	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	No
Secondary	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	Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.	Up to 28 days after completion of study treatment	Yes