Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
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 Carolina | Charleston, South Carolina 29425 |
