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A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in prostate-specific antigen (PSA) level

Outcome Time Frame:

Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.

Safety Issue:


Principal Investigator

Himisha Beltran, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • Metastatic Castrate Resistant Prostate Cancer
  • CRPC
  • Prostatic Neoplasms



Weill Cornell Medical Collgeg New York, New York  10021