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Study of Oxaliplatin and Taxotere in Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00260611
First Posted: December 1, 2005
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Pittsburgh
November 29, 2005
December 1, 2005
March 25, 2015
November 2004
September 2007   (Final data collection date for primary 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. [ Time Frame: Followed for survival ]
Subjects once off treatment wil be followed for survival
To evaluate PSA response rates (response will be defined as a > 50% reduction in PSA levels) in men who have failed primary chemotherapy.
Complete list of historical versions of study NCT00260611 on ClinicalTrials.gov Archive Site
To compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety). [ Time Frame: Follow for survival ]
Subjects will be followed for survival
To compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety).
Not Provided
Not Provided
 
Study of Oxaliplatin and Taxotere in Prostate Cancer
Study of Oxaliplatin and Taxotere in Androgen Independent Prostate Cancer
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).
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Oxaliplatin
    Other Name: eloxatin
  • Drug: Taxotere
    Other Names:
    • Docefrez
    • Docetaxel
Experimental: Oxaliplatin and Taxotere
Patients will receive both docetaxel and oxaliplatin, IV on day 1 of each cycle. Treatment will be repeated every 21 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or >50% increase in serum PSA.
Interventions:
  • Drug: Oxaliplatin
  • Drug: Taxotere
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
September 2007
September 2007   (Final data collection date for primary outcome measure)

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 days.

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.

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00260611
04-011
Yes
Not Provided
Not Provided
University of Pittsburgh
University of Pittsburgh
Sanofi
Principal Investigator: Leonard J Appleman, MD University of Pittsburgh
University of Pittsburgh
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP