Docetaxel, Androgen Ablation Therapy, and External-Beam Radiation Therapy in Treating Patients With High-Risk Localized Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00225420
First received: September 21, 2005
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

RATIONALE: 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 leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy and external-beam radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with androgen ablation therapy and external-beam radiation therapy and to see how well they work in treating patients with high-risk localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: leuprolide acetate
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Concurrent Weekly Docetaxel (Taxotere®), Androgen Ablation, and Adaptive External Beam Radiotherapy for Localized High-Risk Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: when 3 consecutive rising PSA values have been noted ] [ Designated as safety issue: No ]
    PSA progression timepoint is defined as the midpoint between the last non-rising PSA and the first rising PSA.

  • Survival [ Time Frame: until documentation of disease progression ] [ Designated as safety issue: No ]
    Time until there is clinical evidence of disease progression or recurrence on digital rectal examination


Enrollment: 23
Study Start Date: August 2005
Study Completion Date: August 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Single Arm
Drug: docetaxel
Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
Other Name: Taxotere
Drug: leuprolide acetate
Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
Other Names:
  • Lupron
  • Eligard
  • Viadur
  • Zoladex
Radiation: radiation therapy
The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.

Detailed Description:

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when administered in combination with androgen ablation therapy and adaptive external-beam radiotherapy in patients with high-risk localized adenocarcinoma of the prostate.

Secondary

  • Determine the 2-year biochemical progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, open-label, dose-escalation study of docetaxel.

  • Androgen ablation therapy: Patients receive leuprolide acetate or other luteinizing hormone-releasing hormone agonist beginning 2-3 months prior to the start of chemoradiotherapy and continuing for up to 2 years.
  • Chemoradiotherapy: Patients receive docetaxel IV over 1 hour on day 1 and high-dose external-beam radiotherapy on days 1-5. Treatment repeats every 7 days for 8 courses in the absence of disease progression or unacceptable toxicity.

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.

After completion of study treatment, patients are followed every 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • High-risk localized disease, meeting 1 of the following criteria:

    • T3 or T4
    • T1-2 with Gleason score 8-10
    • T1-2 with Gleason score 7 AND PSA ≥ 10 ng/mL
    • T1-2 with any Gleason score AND PSA ≥ 20 ng/mL
  • No evidence of metastatic disease on chest x-ray, bone scan, or CT scan of the abdomen and pelvis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 10 years
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.2 mg/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
  • No peripheral neuropathy > grade 1
  • No myocardial infarction or significant change in anginal pattern within the past year
  • No New York Heart Association class II-IV congestive heart failure
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No other invasive malignancy within the past 5 years except for carcinoma in situ or nonmelanoma skin cancer
  • No concurrent uncontrolled illness, psychiatric condition, or other condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

  • No prior pelvic or prostate radiotherapy for prostate cancer
  • No prior chemotherapy for prostate cancer
  • Prior androgen ablation therapy with luteinizing hormone-releasing hormone agonists allowed provided study treatment is started within 3 months of the initiation of androgen ablation therapy
  • No other concurrent investigational agents
  • Concurrent anticoagulation with stable dose of warfarin or low molecular weight heparin allowed
  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: NCT00225420

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Young Whang, MD, PhD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00225420     History of Changes
Other Study ID Numbers: LCCC 0420, P30CA016086, CDR0000550165
Study First Received: September 21, 2005
Last Updated: September 18, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Leuprolide
Docetaxel
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014