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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

Short name NRR

NCTNCT00225420 (opens ClinicalTrials.gov in a new tab)Other idLCCC 0420
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
23 participants (actual)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2005
Primary completion
Jun 2010
Completion
Aug 2012
First posted
23 Sept 2005 (estimated)
Last update posted
1 Jun 2017
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 1/2

    NRR

    NCT00225420

    Aug 2005 to Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • docetaxelDrug
  • leuprolide acetateDrug
  • radiation therapyRadiation

Arms1

  • Other

    Single Arm Intervention

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Patients Experiencing Dose-Limiting Toxicities

    Time frame · Average follow up of 2 years

    Registry description

    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.

Secondary outcomes(1)

  1. Biochemical Progression-free Survival (PFS)

    Time frame · Average follow up of 2 years

    Registry description

    Measure of the activity of a treatment on a disease. In this study it is measured from the date of enrollment to the date on which the prostate cancer progresses or the date the patient dies. Survival curves were estimated using the Kaplan-Meier technique. Biochemical (PSA) failure is defined, in accordance to the American Society for Therapeutic Radiology and Oncology consensus definition, as three consecutive rise in PSA. The date of biochemical failure is considered to be the midpoint between the last non-rising PSA and the first rising PSA.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Average follow up of 2 years

Number of Patients Experiencing Dose-Limiting Toxicities

GroupValue (Participants)
Docetaxel at 10 mg/m21
Docetaxel 15 mg/m21
Docetaxel 20 mg/m20
Secondary and other outcome results(1)
Secondary outcomeMean· Average follow up of 2 years

Biochemical Progression-free Survival (PFS)

GroupValue (percentage of patients)
Single Arm94

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Single ArmSingle Arm 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 therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments.0 / 180 / 1818 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 120 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. 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 2. No evidence of metastatic disease on chest x-ray, bone scan or CT scan of abdomen/pelvis. 3. Age \> 18 4. The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 5. Peripheral neuropathy: must be \< grade 1 6. Hematologic parameters A) Absolute neutrophil count \> 1,500/mm3 B) Hemoglobin \> 8.0 g/dL C) Platelet count \> 100,000/mm3. 7. 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) 8. 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. 9. Patient must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Exclusion Criteria: 1. Documented metastases on staging studies 2. Life expectancy \<10 years secondary to co-morbid illness 3. 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) 4. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 5. History of invasive malignancy within the last five years prior to study entry except for carcinoma in situ or nonmelanoma skin cancer. 6. Psychiatric conditions which would prevent compliance with treatment or adequate informed consent. 7. Patients receiving another investigational agent during chemo- and radiotherapy 8. Uncontrolled intercurrent illness or other conditions that limit compliance with protocol treatment

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