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Study of Oxaliplatin and Taxotere in Androgen Independent Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Study of Oxaliplatin and Taxotere in Androgen Independent Prostate Cancer

This is a single institution phase II study of oxaliplatin and Taxotere in patients with
androgen independent prostate cancer previously treated with up to two cytotoxic
chemotherapy regimens. During this study, the efficacy and safety of this combination will
be evaluated. The primary objective for this study is to evaluate PSA response rates
(response will be defined as a > 50% reduction in PSA levels) in men who have failed primary
chemotherapy. The secondary objectives are to compare progression free survival, disease
free survival, overall survival, and toxicity (tolerance/safety). There will be up to 35
male subjects >= 18 years of age enrolled on this single institution study.

Inclusion Criteria:

Must have histologically or cytologically confirmed adenocarcinoma consistent clinically
and histologically with carcinoma of the prostate Confirmed androgen independent prostate
cancer (progression despite castrate levels of serum testosterone) Measurable or evaluable
disease (PSA elevation will constitute evaluable disease) 18 years of age. Because no
dosing or adverse event data are currently available on the use of oxaliplatin in patients
< 18 years of age, they are excluded from this study.

Life expectancy of greater than 3 months. ECOG Performance status of 0-1. No more than 2
prior regimens of cytotoxic chemotherapy. Androgen deprivation (castration or LHRH
analogue), and prior antiandrogens allowed.

Patients must be off bicalutamide or nilutamide > 42 days, megestrol or flutamide > 28

Concurrent bisphosphonate therapy allowed. Patients with prior radiotherapy for treatment
of their bony metastases will be included if time since radiation is > 4 weeks, and if PSA
is clearly rising.

Patients must have acceptable organ function as defined as: :WBC > 2500/mm3 or ANC >
1500/mm3, hemoglobin > 9.0 g/dL, platelet count > 100,000/mm3; Bilirubin < 1.5 mg/dL,
SGOT/SGPT < 2 x ULN (< 4 x ULN if liver metastases present), PT/PTT normal; Creatinine <
1.8 mg/dL Adequate neurologic function defined as no clinically significant peripheral
neuropathy, defined as any neuropathy ≤ grade 1.

Adequate cardiovascular function defined as no active congestive heart failure, no
uncontrolled angina, no myocardial infarction within the past 6 months.

Exclusion Criteria:

No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment. May
not be taking other investigational drugs while on trial.

Patients with known brain metastases should be excluded from this clinical trial because
of their poor prognosis and because they often develop progressive neurologic dysfunction
that would confound the evaluation of neurologic and other adverse events.

No prior therapy with oxaliplatin is allowed. No history of allergic reactions attributed
to the drugs used in this study or compounds of similar chemical or biologic composition.

No history of intolerance or allergy to the antiemetics to be administered in conjunction
with the study drugs (i.e., 5 HT3 antagonists).

No concurrent other active cancer from another primary site, except squamous cell and
basal cell carcinoma of the skin.

No other serious concomitant illness will be allowed, including interstitial pneumonia,
extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable
angina, symptomatic congestive heart failure, NYHA Class III or IV, serious cardiac
arrhythmia, uncontrolled diabetes mellitus or active infection.

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy.

Outcome Description:

Subjects once off treatment wil be followed for survival

Outcome Time Frame:

Followed for survival

Safety Issue:


Principal Investigator

Leonard J Appleman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

November 2004

Completion Date:

September 2007

Related Keywords:

  • Prostate Cancer
  • prostate
  • Prostatic Neoplasms



Hillman Cancer Center Pittsburg, Pennsylvania  15232