Clinical trial · Interventional
Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy
A Randomized Study of Cetuximab or Cetuximab Plus Docetaxel Followed by Radical Prostatectomy for Patients With Adenocarcinoma of the Prostate
NCT00448097CI-TRIAL-00021405terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of patient population - slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Data not available PI relocated
- description
- No verifiable data available, PI relocated
- interventionNames
- Drug: cetuximab
- Drug: docetaxel
Primary outcomes (2)
- measure
- Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
- timeFrame
- during study
- description
- No verifiable data available, PI relocated
- measure
- Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy
- timeFrame
- during study
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDPrewett 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