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Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy

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ClinicalTrials.gov Identifier: NCT00448097
Recruitment Status : Terminated (lack of patient population - slow accrual)
First Posted : March 15, 2007
Last Update Posted : March 17, 2016
Sponsor:
Collaborators:
Bristol-Myers Squibb
Eli Lilly and Company
Information provided by (Responsible Party):
The Methodist Hospital System

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 of the prostate.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: cetuximab Drug: docetaxel Phase 2

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. There is a higher risk of treatment failure in any patient with a tumor that extends through the prostate capsule, more aggressive pathology (Gleason score of 7 or higher), or patients with a PSA of greater than 10 ng/ml. The rationale for adding molecular targeted drugs such as Cetuximab (epithelial growth factor inhibitor), with or without chemotherapy such as Docetaxel, is that such therapy has the potential to demonstrate tumor shrinkage of the prostate and, in addition, micrometastatic cells. Cetuximab alone or Cetuximab plus Docetaxel utilizing the preprostatectomy model, with the adjuvant delivery of Cetuximab for 6 months, will provide data for the following points:

  1. demonstration of a PSA response prior to prostatectomy;
  2. demonstration whether a change in the natural history, with a delay in the onset of metastatic disease in patients with advanced local prostate cancer, can be achieved;
  3. laboratory and tissue correlation to assess changes in proliferative, apoptosis, and pathologic parameters; and
  4. metabolic imaging utilizing CT-PET with FDG to assess whether this will be a useful modality in exhibiting a response to therapy, compared with conventional radiographic imaging.

This will provide the basis for future development of neoadjuvant chemotherapy prior to prostatectomy.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study of Cetuximab or Cetuximab Plus Docetaxel Followed by Radical Prostatectomy for Patients With Adenocarcinoma of the Prostate
Study Start Date : February 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Data not available PI relocated
No verifiable data available, PI relocated
Drug: cetuximab
No verifiable data available, PI relocated
Other Name: Erbitux

Drug: docetaxel
No verifiable data available, PI relocated
Other Name: Taxotere




Primary Outcome Measures :
  1. Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10 [ Time Frame: during study ]
    No verifiable data available, PI relocated

  2. Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy [ Time Frame: during study ]
    No verifiable data available, PI relocated


Secondary Outcome Measures :
  1. PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy [ Time Frame: during study ]
    No verifiable data available, PI relocated

  2. Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3 [ Time Frame: during study ]
    No verifiable data available, PI relocated

  3. Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery [ Time Frame: during study ]
    No verifiable data available, PI relocated

  4. Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy [ Time Frame: during study ]
    No verifiable data available, PI relocated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448097


Locations
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United States, Texas
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Bristol-Myers Squibb
Eli Lilly and Company
Investigators
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Principal Investigator: Robert J Amato, DO Baylor College of Medicine - Methodist Hospital

Publications:
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Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00448097     History of Changes
Other Study ID Numbers: HMRI IRB#0206-0027
E-VS-ET-2006 ( Other Identifier: Principal Investigator )
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Methodist Hospital System:
Adenocarcinoma of the Prostate
Prostate cancer
Pre-Prostatectomy
Neoadjuvant
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological