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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00482807
First received: June 4, 2007
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: docetaxel
Drug: goserelin
Radiation: intensity-modulated radiation therapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: time to Prostate Specific Antigen (PSA) failure ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: August 2004
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482807

Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Ralph Hauke, MD University of Nebraska
Study Chair: Elizabeth C. Reed, MD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Ralph Hauke, M.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00482807     History of Changes
Other Study ID Numbers: 195-04, P30CA036727, UNMC-19504
Study First Received: June 4, 2007
Last Updated: February 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Bicalutamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014