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Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis

Phase 1
19 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis



- 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.


- Determine, preliminarily, the progression-free survival of patients treated with this

- 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.

Inclusion Criteria


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity rate as assessed by NCI CTCAE v3.0

Outcome Time Frame:

during therapy and follow-up visits to continue for 5 years after radiation is completed

Safety Issue:


Principal Investigator

Ralph Hauke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Institutional Review Board

Study ID:




Start Date:

August 2004

Completion Date:

March 2010

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Neoplasm Metastasis
  • Prostatic Neoplasms



UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680