Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
Interventions
DRUGdocetaxel
Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
Sponsors
National Cancer Institute (NCI)
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml | While receiving study treatment (approximately 6 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml) | Average days to develop recurrence from treatment start date amount applicable participants | Average time for participants to develop PSA recurrence (PSA \> 0.2ng/ml). Due to the limited enrollment, this analysis was not completed. |
| Time to Metastatic Disease | Measured at Time of documented metastases (no historical estimate is available) | Due to the limited enrollment, this analysis was not completed. |
| Time to Androgen Independent State | Measured at date of documented androgen independence (no estimate available) | Due to the limited enrollment, this analysis was not completed. |
| Time to Death From Any Cause | measured at date of death (no estimate available) | Due to the limited enrollment, this analysis was not completed. |
Countries
United States
Participant flow
Recruitment details
Three subjects were enrolled between 11/08 and 4/09 from the oncology clinic at OHSU. Enrollment was terminated on 11/30/09, when the sponsor withdrew funding for this study.
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Docetaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 2.49 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: While receiving study treatment (approximately 6 months)
Population: Analysis includes all subjects who completed study regimen of 6 cycles.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel | Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml | 1 participants |
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.
Time frame: Average days to develop recurrence from treatment start date amount applicable participants
Population: Due to the limited enrollment, this analysis was not completed.
Secondary
Time to Androgen Independent State
Due to the limited enrollment, this analysis was not completed.
Time frame: Measured at date of documented androgen independence (no estimate available)
Population: Due to the limited enrollment, this analysis was not completed.
Secondary
Time to Death From Any Cause
Due to the limited enrollment, this analysis was not completed.
Time frame: measured at date of death (no estimate available)
Population: Due to the limited enrollment, this analysis was not completed.
Secondary
Time to Metastatic Disease
Due to the limited enrollment, this analysis was not completed.
Time frame: Measured at Time of documented metastases (no historical estimate is available)
Population: Due to limited enrollment, this analysis was not completed