Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients

NCT00714376 | Terminated Phase 2 DMC

• 1 other identifier: Project 5.2.08.02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy given as a primary treatment to patients with early and rapid PSA rising after prostatectomy for high risk disease.

Conditions

Prostate Cancer

Keywords

Prostate cancer; High-risk prostate cancer; Radical prostatectomy; Early rising PSA; Taxotere; Docetaxel

Outcome Measures

Primary Outcomes (1)

• To evaluate the rate of partial and complete biochemical response to 8 cycles of Taxotere in patients with early (<2 years) PSA recurrence after radical prostatectomy with a PSA doubling time of <=9 months.

  3 to 6 months

Secondary Outcomes (1)

• To evaluate the response rate to subsequent androgen deprivation therapy in patients not responding and in those having a biochemical recurrence after complete response.

  3-6 months

Study Arms (1)

Docetaxel

EXPERIMENTAL

Docetaxel (Taxotere) 75 mg/m² IV every 3 weeks for 8 cycles.

Drug: Docetaxel

Interventions

Docetaxel DRUG

75 mg/m2 iv every 3 weeks for 8 cycles

Also known as: Taxotere

Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of prostate adenocarcinoma on a radical prostatectomy.
• Prior radical prostatectomy within less than 2 years from the time of first PSA rise.
• Demonstration of biochemical recurrence based on a PSA detectable \>0.03 less than 24 months after radical prostatectomy and confirmed on 2 additional tests.
• PSA doubling time over three values must be \<= 9 months for PSA \>=0.4 and PSA \<=10. If PSA is \>10, there is no need for PSA doubling time.
• Karnofsky performance status (KPS) \>=70%
• Adequate organ function as defined by hemogram with haemoglobin \>8.0, platelet \>100 000, white blood cell \>3,500, creatinine clearance \>=60 cc/min and normal liver function tests.
• Neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that the total duration of therapy did not exceed 6 months.
• Subjects must have signed an informed consent document stating that they understand the investigational or nature of the proposed treatment.
• Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.

You may not qualify if:

• Clinical significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
• Uncontrolled serious active infection.
• Anticipated duration of life less than 2 years.
• Less than 5-year history of successful treatment for other cancers or concurrent active non prostate cancer other than non melanoma dermatologic tumors and non-muscle invasive bladder tumors.
• Peripheral neuropathy \>=2 grade 2
• Concurrent experimental treatment or involvement in other clinical trials involving drugs.
• Other severe acute or chronic medical conditions including psychiatric diseases or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety.
• Subjects who participated in another clinical study/received investigational product within 30 days of screening for this study.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Centre de recherche clinique et evaluative en oncologie, L'Hôtel-Dieu de Québec-CHUQ

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

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

Study Officials

• Yves Fradet, MD

  Centre Hospitalier Universitaire de Quebec (CHUQ)

  PRINCIPAL INVESTIGATOR

• Pierre Ouellet, MD

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist-Oncologist

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

CA (1)