Clinical trial NCT00482274: Docetaxel in Treating Patients With Relapsed Prostate Cancer
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-05
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
timeFrame: While receiving study treatment (approximately 6 months)
Secondary outcomes:
measure: Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)
timeFrame: Average days to develop recurrence from treatment start date amount applicable participants
measure: Time to Metastatic Disease
timeFrame: Measured at Time of documented metastases (no historical estimate is available)
measure: Time to Androgen Independent State
timeFrame: Measured at date of documented androgen independence (no estimate available)
measure: Time to Death From Any Cause
timeFrame: measured at date of death (no estimate available)
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Seattle
country: United States
facility: University Cancer Center at University of Washington Medical Center
state: Washington
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Tomasz M. Beer, MD
role: PRINCIPAL_INVESTIGATOR
References: