Prostate Cancer
Conditions
Keywords
Metastatic Castrate Resistant Prostate Cancer, CRPC
Brief summary
The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.
Detailed description
Docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant prostate cancer (CRPC) but duration of response is limited, with median time to prostate-specific antigen (PSA) progression of 6-8 months. There is currently no standard second-line therapy for patients who have progressed after receiving docetaxel. Carboplatin and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this regimen are limited. In addition, correlative studies investigating why some patients respond are lacking.
Interventions
DRUGCarboplatin
AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
DRUGPaclitaxel
80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
Sponsors
Weill Medical College of Cornell University
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
* Histologic or cytologic diagnosis of prostate carcinoma. * Subject must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. Furthermore, if applicable, medical castration must be maintained for the duration of the protocol. * Serum testosterone \< 50 ng/ml. * Subjects who have received anti-androgen therapy with a resulting PSA decline must demonstrate progression following discontinuation of anti-androgen therapy. * Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial. * Must have previously received docetaxel for prostate cancer * ECOG performance status 0-2 * Willing and able to give informed consent
Exclusion criteria
* Platelet count \<100,000/mm3 * Absolute neutrophil count (ANC) \<1,500/mm3 * Hemoglobin \< 8 g/dL * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 x upper limit of normal * Bilirubin (total) \>2 x upper limit of normal. Subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits * For subjects with serum creatinine \> 1.5 x ULN, calculated creatinine clearance \< 30 ml/min are excluded; subjects meeting this exclusion criterion are eligible if a measured clearance is \> 30 ml/min * Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study * Prior investigational therapy within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase. * Grade \> 1 peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prostate-specific Antigen (PSA) Level | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study. | — |
| Change in Tumor Size | Baseline, week 12, week 24 and end of study. | Assessed by CT or MRI scan and/or bone scan. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Survival Status | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Carboplatin and Paclitaxel
Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| 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 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Change in Prostate-specific Antigen (PSA) Level
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.
Population: This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.
Primary
Change in Tumor Size
Assessed by CT or MRI scan and/or bone scan.
Time frame: Baseline, week 12, week 24 and end of study.
Population: This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.
Secondary
Change in Survival Status
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.
Population: This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.