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Intensity-Modulated Radiation Therapy, Docetaxel, and Hormone Therapy in Treating Patients With High-Risk Locally Advanced Prostate Cancer With Pelvic Lymph Node Metastasis

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bicalutamide
docetaxel
goserelin
intensity-modulated radiation therapy
Sponsored by
University of Nebraska
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

19 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Locally advanced disease (T1 -T3b, N1 or N2, M0) at high risk for recurrence

      • Biopsy-proven pelvic lymph node involvement
      • No T4 lesion

  • Prior androgen suppression within the past 14 months is allowed provided the following criterion is met:

    • No biochemical evidence of PSA progression after androgen withdrawal

      • PSA progression, defined as 2 consecutive rising PSA values > 4.0 ng/mL taken ≥ 2 weeks apart

  • No evidence of distant metastasis, including any of the following:

    • Bone metastasis
    • Pathologic or radiographic evidence of lymph node involvement above the L4 - L5 interspace

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 80-100%
  • ANC ≥ 1,500/mm³
  • Hemoglobin ≥ 10 g/dL
  • Platelet count > 100,000/mm³
  • Bilirubin normal
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment

  • Meets 1 of the following criteria:

    • Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal
  • No peripheral neuropathy > grade 1
  • No significant comorbidity that would preclude radiotherapy
  • No other prior malignancy except nonmelanoma skin cancer or any other cancer for which the patient has been disease-free for the past 5 years
  • No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
  • No history of Crohn's disease, ulcerative colitis, or irritable bowel syndrome
  • No unrepaired inguinal hernia

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy or prostate brachytherapy implant
  • No prior prostatectomy
  • No prior pelvic or abdominal surgery that resulted in excessive amounts of small intestine located within the pelvis
  • No other concurrent investigational agents

Sites / Locations

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Outcomes

Primary Outcome Measures

Toxicity rate as assessed by NCI CTCAE v3.0

Secondary Outcome Measures

Progression-free survival
Maximum tolerated dose (MTD) of docetaxel

Full Information

First Posted
June 4, 2007
Last Updated
February 22, 2018
Sponsor
University of Nebraska
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00482807
Brief Title
Intensity-Modulated Radiation Therapy, Docetaxel, and Hormone Therapy in Treating Patients With High-Risk Locally Advanced Prostate Cancer With Pelvic Lymph Node Metastasis
Official Title
Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with chemotherapy and hormone therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
Detailed Description
OBJECTIVES: Primary Determine, preliminarily, the grade III or IV toxicity rate of concurrent extended-field intensity-modulated radiotherapy (IMRT), docetaxel, and androgen deprivation therapy in patients with high-risk, locally advanced prostate cancer with pelvic lymph node metastasis. Secondary Determine, preliminarily, the progression-free survival of patients treated with this regimen. Determine the maximum tolerated dose of docetaxel when administered with concurrent IMRT in this patients. OUTLINE: This is a dose-escalation study of docetaxel. Patients receive combined androgen deprivation therapy (if not already on combined hormonal therapy) comprising goserelin acetate* subcutaneously once every 3 months for up to 2 years and oral bicalutamide once daily beginning on day 1 and continuing until the completion of radiotherapy. Beginning at approximately week 9 of androgen deprivation therapy, patients receive docetaxel IV over 1 hour once weekly for up to 9 weeks. Concurrently with chemotherapy, patients undergo intensity-modulated radiotherapy 5 days a week for up to 45 fractions (9 weeks). Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. NOTE: *Not required for patients who have undergone bilateral orchiectomy After completion of study therapy, patients are followed periodically for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
goserelin
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Primary Outcome Measure Information:
Title
Toxicity rate as assessed by NCI CTCAE v3.0
Time Frame
during therapy and follow-up visits to continue for 5 years after radiation is completed
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
time to Prostate Specific Antigen (PSA) failure
Title
Maximum tolerated dose (MTD) of docetaxel
Time Frame
Trial stopped: dose below which excess DLT observed. If 3 patients treated at that dose, then added 3 should be entered, that process proceeds down, so MTD becomes highest dose where no more than 1 toxicity observed in 6 patients.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Locally advanced disease (T1 -T3b, N1 or N2, M0) at high risk for recurrence Biopsy-proven pelvic lymph node involvement No T4 lesion Prior androgen suppression within the past 14 months is allowed provided the following criterion is met: No biochemical evidence of PSA progression after androgen withdrawal PSA progression, defined as 2 consecutive rising PSA values > 4.0 ng/mL taken ≥ 2 weeks apart No evidence of distant metastasis, including any of the following: Bone metastasis Pathologic or radiographic evidence of lymph node involvement above the L4 - L5 interspace PATIENT CHARACTERISTICS: Karnofsky performance status 80-100% ANC ≥ 1,500/mm³ Hemoglobin ≥ 10 g/dL Platelet count > 100,000/mm³ Bilirubin normal Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST or ALT normal No peripheral neuropathy > grade 1 No significant comorbidity that would preclude radiotherapy No other prior malignancy except nonmelanoma skin cancer or any other cancer for which the patient has been disease-free for the past 5 years No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80 No history of Crohn's disease, ulcerative colitis, or irritable bowel syndrome No unrepaired inguinal hernia PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior pelvic or abdominal radiotherapy or prostate brachytherapy implant No prior prostatectomy No prior pelvic or abdominal surgery that resulted in excessive amounts of small intestine located within the pelvis No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Hauke, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth C. Reed, MD
Organizational Affiliation
University of Nebraska
Official's Role
Study Chair
Facility Information:
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intensity-Modulated Radiation Therapy, Docetaxel, and Hormone Therapy in Treating Patients With High-Risk Locally Advanced Prostate Cancer With Pelvic Lymph Node Metastasis

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