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

NCT00225420 | Completed Phase 1 Results DMC

• 1 other identifier: LCCC 0420
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing Dose-Limiting Toxicities

  Determine the number of patients experiencing dose-limiting toxicities (DLT) at each dose level. DLT was defined as grade 3-4 non-haematological or grade 4 haematological toxicity, using the Common Terminology Criteria for Adverse Events, version 3.0.

  Average follow up of 2 years

Secondary Outcomes (1)

• Biochemical Progression-free Survival (PFS)

  Average follow up of 2 years

Study Arms (1)

Single Arm Intervention

OTHER

Single Arm Intervention where after enrollment (or prior to enrollment but before starting radiotherapy) patients will initially receive leuprolide acetate (Lupron®) intramuscular (IM). Patients will begin adaptive external-beam radiation therapy 2-3 months following the initiation of hormonal therapy. Each patient receives a dose of docetaxel at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight weeks.

Drug: docetaxel; Drug: leuprolide acetate; Radiation: radiation therapy

Interventions

docetaxel DRUG

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.

Also known as: Taxotere

Single Arm Intervention

leuprolide acetate DRUG

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.

Also known as: Lupron, Eligard, Viadur, Zoladex

Single Arm Intervention

radiation therapy RADIATION

The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.

Single Arm Intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate with any of following clinical features:
• A) T3 or T4 B) T1-2 + Gleason Score 8-10 C) T1-2 + Gleason Score 7 + Prostate Specific Antigen (PSA) \>10 ng/mL D) T1-2 + Any Gleason Score + PSA \>20 ng/mL
• No evidence of metastatic disease on chest x-ray, bone scan or CT scan of abdomen/pelvis.
• Age \> 18
• The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Peripheral neuropathy: must be \< grade 1
• Hematologic parameters A) Absolute neutrophil count \> 1,500/mm3 B) Hemoglobin \> 8.0 g/dL C) Platelet count \> 100,000/mm3.
• Hepatic parameters / Renal function A) Total Bilirubin must be ≤ 1.2 mg/dL B) Transaminases (AST and ALT) must be \< 1.5 x upper limit of normal (ULN) C) Alkaline phosphatase must be \< 2.5 x ULN D) Creatinine \< 1.5 x ULN ( \< 2.1 mg/dL)
• No prior pelvic or prostate radiation or chemotherapy for prostate cancer. Androgen ablation therapy with one of the luteinizing hormone-releasing hormone (LH-RH) agonists prior to enrollment is acceptable as long as protocol treatment with radiotherapy and chemotherapy is started within 3 months of the initiation of androgen ablation.
• Patient must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

You may not qualify if:

• Documented metastases on staging studies
• Life expectancy \<10 years secondary to co-morbid illness
• Myocardial infarction or significant change in anginal pattern within one year prior to study entry or current congestive heart failure (New York Heart Association Class 2 or higher)
• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• History of invasive malignancy within the last five years prior to study entry except for carcinoma in situ or nonmelanoma skin cancer.
• Psychiatric conditions which would prevent compliance with treatment or adequate informed consent.
• Patients receiving another investigational agent during chemo- and radiotherapy
• Uncontrolled intercurrent illness or other conditions that limit compliance with protocol treatment

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Sanofi: collaborator

Study Sites (2)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Leuprolide; luprolide acetate gel depot; Goserelin; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Results Point of Contact

• Title: Robin V. Johnson
• Organization: Lineberger Comprehensive Cancer Center

robin_v_johnson@med.unc.edu

919-966-1125

Study Officials

• Young Whang, MD, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2012
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-04

Locations

US (2)