Study of Oxaliplatin and Taxotere in Prostate Cancer

NCT00260611 | Completed Phase 2 DMC

• 1 other identifier: 04-011
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer

Keywords

prostate

Outcome Measures

Primary Outcomes (1)

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

  Subjects once off treatment wil be followed for survival

  Followed for survival

Secondary Outcomes (1)

• To compare progression free survival, disease free survival, overall survival, and toxicity (tolerance/safety).

  Follow for survival

Study Arms (1)

Oxaliplatin and Taxotere

EXPERIMENTAL

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.

Drug: Oxaliplatin; Drug: Taxotere

Interventions

Oxaliplatin DRUG

Also known as: eloxatin

Oxaliplatin and Taxotere

Taxotere DRUG

Also known as: Docefrez, Docetaxel

Oxaliplatin and Taxotere

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Sanofi: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Leonard J Appleman, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: November 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

US (1)