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

Prostate Cancer Clinical Trial

— NRR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225420
• Other study ID #: LCCC 0420
• Secondary ID: P30CA016086CDR00
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 21, 2005
• Last updated: January 20, 2016
• Start date: August 2005
• Est. completion date: August 2012

Study information

• Verified date: January 2016
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Radiation:
• radiation therapy
The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	PSA progression timepoint is defined as the midpoint between the last non-rising PSA and the first rising PSA.	when 3 consecutive rising PSA values have been noted	No
Primary	Survival	Time until there is clinical evidence of disease progression or recurrence on digital rectal examination	until documentation of disease progression	No