Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01558492

Run by

Weill Medical College of Cornell University

People needed

3

Starts

2011-03-01

Expected to finish

2013-11-01

Last updated by the study team

2017-06-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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