Clinical trial NCT01558492: Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer
Official title: A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Metastatic Castrate Resistant Prostate Cancer
CRPC
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-03-20
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Prostate-specific Antigen (PSA) Level
timeFrame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.
measure: Change in Tumor Size
timeFrame: Baseline, week 12, week 24 and end of study.
Secondary outcomes:
measure: Change in Survival Status
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Himisha Beltran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: