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Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of docetaxel, when given in combination with
radiotherapy and hormonal therapy, in patients with high-risk clinically locally
advanced prostate cancer.

Secondary

- Determine progression-free survival and time to prostate-specific antigen failure in
patients treated with this regimen.

OUTLINE: This is a dose-escalation study of docetaxel.

Patients receive goserelin subcutaneously (SC) OR leuprolide intramuscularly (IM) once
monthly AND oral bicalutamide once daily for 2 months. Patients then receive docetaxel IV
over 30 minutes on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Concurrent with chemotherapy,
patients undergo radiotherapy on days 1-5 weekly for 8.6 weeks (43 fractions). Patients
continue to receive goserelin SC OR leuprolide IM once monthly during chemotherapy and
radiotherapy and then every 3 months for 2 years. Treatment continues 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.

Patients are followed every 3 months for 2 years, every 6 months for 4 years, and then
annually therafter.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Clinically locally advanced disease, defined as 1 of the following:

- T_xN_0M_0 AND prostate-specific antigen (PSA) ≥ 20 ng/mL AND Gleason score
≥ 7

- T_3b,4N_0M_0 AND any PSA and Gleason score

- T_xN_0M_0 AND any PSA AND Gleason score ≥ 8

- No pelvic lymph node disease that would necessitate pelvic radiotherapy

- No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the
abdomen or pelvis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin normal

- Meets 1 of the following criteria:

- AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ ULN

- AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

- AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No uncontrolled cardiac disease

Other

- Fertile patients must use effective contraception during and for 3 months after study
participation

- HIV negative

- No peripheral neuropathy > grade 1

- No uncontrolled infection

- No uncontrolled diabetes mellitus

- No psychiatric illness that would preclude patient from giving informed consent

- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with Polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy for prostate cancer

- No concurrent sargramostim (GM-CSF) or filgrastim (G-CSF)

Chemotherapy

- No prior chemotherapy for prostate cancer

- No other concurrent chemotherapy

Endocrine therapy

- Prior androgen deprivation therapy allowed for up to 4 weeks before study entry

- No concurrent hormone therapy except for the following:

- Steroids for adrenal insufficiency

- Hormones for non-disease-related conditions (e.g., insulin for diabetes)

- Intermittent dexamethasone as an antiemetic or as premedication for docetaxel
administration

Radiotherapy

- No prior radiotherapy for prostate cancer

- No concurrent radiotherapy, including palliative radiotherapy

Surgery

- At least 4 weeks since prior major surgery

Other

- No prior alternative therapy for prostate cancer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Andrew S. Kraft, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000387959

NCT ID:

NCT00099086

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425