Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate (2007-5904)
Primary Purpose
Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docetaxel
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, Prostatectomy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (docetaxel and prednisone)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rates of tumor response
Expressed with two-sided exact binomial confidence intervals.
The rate of negative surgical margin
The proportion of patients with pathological down-staging defined as evidence of decreased pathological stage or Gleason score when compared with pretreatment pathological stage
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.
Full Information
NCT ID
NCT00598858
First Posted
January 10, 2008
Last Updated
December 6, 2016
Sponsor
John P. Fruehauf
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00598858
Brief Title
Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Halted due to zero accrual and lack of funding
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John P. Fruehauf
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer
Keywords
prostate cancer, Prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (docetaxel and prednisone)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
114977-28-5, 40466, 628503, RP 56976, RP56976, Taxotere, TXT
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
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
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
PSA response rate (partial response (PR) + complete response (CR))
Description
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.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Rates of tumor response
Description
Expressed with two-sided exact binomial confidence intervals.
Time Frame
Up to 7 days after completion of study treatment
Title
The rate of negative surgical margin
Time Frame
Up to 7 days after completion of study treatment
Title
The proportion of patients with pathological down-staging defined as evidence of decreased pathological stage or Gleason score when compared with pretreatment pathological stage
Time Frame
Up to 7 days after completion of study treatment
Title
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
Description
Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame
Up to 28 days after completion of study treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Fruehauf, MD, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate
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