Docetaxel in Treating Patients With Relapsed Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00482274
• Other study ID #: CDR0000546975
• Secondary ID: P30CA069533OHSU-
• Status: Terminated
• Phase: Phase 2
• First received: June 4, 2007
• Last updated: April 26, 2017
• Start date: May 2007
• Est. completion date: July 2009

Study information

• Verified date: April 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• 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.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.

Description:

OBJECTIVES:

Primary

• Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.

Secondary

• Determine the time to PSA recurrence in patients receiving this treatment.

• Determine the time to metastatic disease in patients receiving this treatment.

• Determine the time to androgen independent state in patients receiving this treatment.

• Determine the time to death from any cause in patients receiving this treatment.

OUTLINE: This is an open label study.

Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Criteria for Patient eligibility

Inclusion criteria

1. Histologically confirmed adenocarcinoma of the prostate.

2. Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.

3. Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months.

4. Serum testosterone < 50 ng/ml.

5. No evidence of metastases on bone scan.

6. No evidence of metastases on CT scan of the abdomen and pelvis.

7. ECOG performance status < 2.

8. Laboratory criteria for entry: absolute neutrophil count = 1.2 K/cu mm, platelets = 100 K/cu mm, serum bilirubin = upper limit of normal (ULN), SGOT and SGPT = 1.5 times institutional ULN if alkaline phosphatase = ULN, alkaline phosphatase = 5 times ULN if SGOT and SGPT are = ULN, a serum creatinine = 2 times institutional ULN.

9. Signed informed consent.

Exclusion Criteria

1. A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.

2. Life expectancy < 3 months.

3. Grade 2 or higher peripheral neuropathy.

4. Prior investigational agent within the past 28 days.

5. Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy.

6. More than 12 months since initiation of androgen-deprivation therapy.

7. Prior docetaxel chemotherapy.

8. Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel
Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml	Complete response rate, as measured by PSA and defined as a PSA =0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.	While receiving study treatment (approximately 6 months)
Secondary	Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)	Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.	Average days to develop recurrence from treatment start date amount applicable participants
Secondary	Time to Metastatic Disease	Due to the limited enrollment, this analysis was not completed.	Measured at Time of documented metastases (no historical estimate is available)
Secondary	Time to Androgen Independent State	Due to the limited enrollment, this analysis was not completed.	Measured at date of documented androgen independence (no estimate available)
Secondary	Time to Death From Any Cause	Due to the limited enrollment, this analysis was not completed.	measured at date of death (no estimate available)