Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer
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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. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy 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 with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: docetaxel Drug: goserelin acetate Drug: leuprolide acetate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer |
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Study Chair: | Andrew S. Kraft, MD | Medical University of South Carolina |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00099086 History of Changes |
| Other Study ID Numbers: | CDR0000387959, MUSC-100783, MUSC-HR-11326, AVENTIS-MUSC-100783 |
| Study First Received: | December 8, 2004 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medical University of South Carolina:
|
adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Leuprolide Goserelin Docetaxel Bicalutamide |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013