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

NCT00448097 | Terminated Phase 2

• 2 other identifiers: HMRI IRB#0206-0027E-VS-ET-2006
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Adenocarcinoma of the Prostate; Prostate cancer; Pre-Prostatectomy; Neoadjuvant

Outcome Measures

Primary Outcomes (2)

• Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10

  No verifiable data available, PI relocated

  during study

• Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy

  No verifiable data available, PI relocated

  during study

Secondary Outcomes (4)

• PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy

  during study

• Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3

  during study

• Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery

  during study

• Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy

  during study

Study Arms (1)

Data not available PI relocated

OTHER

No verifiable data available, PI relocated

Drug: cetuximab; Drug: docetaxel

Interventions

cetuximab DRUG

No verifiable data available, PI relocated

Also known as: Erbitux

Data not available PI relocated

docetaxel DRUG

No verifiable data available, PI relocated

Also known as: Taxotere

Data not available PI relocated

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Bristol-Myers Squibb: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Prewett M, Rockwell P, Rockwell RF, Giorgio NA, Mendelsohn J, Scher HI, Goldstein NI. The biologic effects of C225, a chimeric monoclonal antibody to the EGFR, on human prostate carcinoma. J Immunother Emphasis Tumor Immunol. 1996 Nov;19(6):419-27. doi: 10.1097/00002371-199611000-00006.

  PMID: 9041461 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cetuximab; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Robert J Amato, DO

  Baylor College of Medicine - Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 15, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)