Status:
TERMINATED
Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Eli Lilly and Company
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to differentiate between the administrations of Cetuximab alone vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the surgical removal...
Detailed Description
With the larger number of men who undergo screening with assays for serum prostate specific antigen, urologists continue to see considerable numbers of patients with locally advanced prostate disease....
Eligibility Criteria
Inclusion
- Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade 7 or above with a PSA ≥ 10ng/ml, or clinical stage T3.
- Recent (\< 6 weeks prior to study entry) negative bone scan and MRI of abdomen and pelvis.
- Appropriate surgical candidate for radical prostatectomy and a performance status of \< 2 (Zubrod scale).
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count \> 1,500 and platelet count of \> 100,000, adequate hepatic function with a bilirubin \< 1.5 mg % and SGPT \< 2.5x the upper limits of normal, adequate renal function defined as serum creatinine \< 1.5 x ULN.
- Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
- Patients must have no history of congestive heart failure or previous MI within the last 12 months.
Exclusion
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
- Unable to tolerate transrectal ultrasound.
- Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
- Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.
- Patients on oral steroid medications are not eligible.
- Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible.
- Prior severe infusion reaction to a monoclonal antibody.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00448097
Start Date
February 1 2007
End Date
August 1 2008
Last Update
March 17 2016
Active Locations (1)
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1
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030