Safety and Efficacy Study of ABX-EGF in Patients With Renal Cancer, Part 2

Study Overview
=================
Brief Summary
-----------------
Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk in 2 cohorts.

Official Title
-----------------
A Two-part, Multiple Dose Clinical Trial Evaluating the Safety and Effectiveness of ABX-EGF in Patients With Renal Carcinoma

Conditions
-----------------
Advanced Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Panitumumab (ABX-EGF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to comprehend and sign an IRB approved Informed Cosent Form Male or female 18 years of age or older Female patients who are post menopausal (no menstrual period for a minimum of six months), surgically sterilized, or are using an oral or implanted contraceptive, double barrier birth control, or an IUD and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment into this study Pathologic diagnosis of renal cell carcinoma by fine needle aspirate or tissue biopsy Prior nephrectomy Prior Therapy: Cohort 1 only: Previously received and failed one prior biotherapy, defined as IL-2 therapy or interferon-alpha (alone or in combination); Karnosky score of > or = 70% Cohort 2 only: No prior therapy except nephrectomy and fall within the Motzer intermediate group with one or two of the risk factors, as defined in teh Study Design section. Has bi-dimensionally measurable disease Has tumor tissue available for diagnostics (acceptable: biopsy, nephrectomy tissue, fine needle aspirate, or archived tissue that is formalin fixed and paraffin embedded). In cases when a fresh biopsy can be obtained, the biopsy should be divided into two; one half should be formalin fixed, and the other half frozen. Tumor samples must be received at the central laboratory prior to patient regisration. Adequate hematologic data, as follows: ANC > 1.5 x 109/L Platelet count > 100x 109/L Adequate renal function, as follows: 1. Creatinine < or = 2.2mg/dL Adequate hepatic function, as follows: Alkaline phosphatase < or = 3x ULN AST < or = 3x ULN ALT < or = 3x ULN Total bilirubin < or = 1.5x ULN Exclusion Criteria: Brain metastases Cohort 1 only: Hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed) Cancer therapy within 30 days of ABX-EGF infusion (hormone therapy is allowed; steroid therapy is only allowed if it is replacement therapy) Use of any investigational drug within 30 days of ABX-EGF infusion Prior treatment with any anti-EGFr agents Left ventricular ejection fraction < 45%, as measured by MUGA Scan Myocardial infarction within one year prior to entering the study Has other cancer that has been active and required treatment within the past 5 years (prior renal cell carcinoma, basal cell carcinoma, or cervical carcinoma in situ are allowed) Pregnant or breast feeding female; male or female of childbearing potential (defined as: post menarche and is biologically capable of becoming pregnant) unwilling to use birth control (as defined in the inclusion criteria) during and for 1 month following treatment Known to be HIV positive History of any chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risks associated with study participation or study drug administration or may interfere with the interpretation of study results Allergy to the ingredients of the study medication or to Staphylococcus Protein A

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Panitumumab (ABX-EGF)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2, Cohort 1: Efficacy: Tumor response rate (CR or PR) measured at 8 weeks |  |  | 
| Part 2, Cohort 1: Safety: Incidence and severity of AEs |  |  | 
| Part 2, Cohort 2: Time to disease progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2, Cohort 1: Time to disease progression |  |  | 
| Part 2, Cohorts 1 & 2: Survival time |  |  | 
| Part 2, Cohorts 1 & 2: PFS |  |  | 
| Part 2, Cohorts 1 & 2: Best overall response rate |  |  | 
| Part 2, Cohorts 1 & 2: Tumor response rate at Weeks 15, 23, 31, and 39 |  |  | 
| Part 2, Cohorts 1 & 2: Duration of response |  |  | 
| Part 2, Cohorts 1 & 2: Percent of patients with progressive disease (measured at 8 weeks following initiation of panitumumab treatment) |  |  | 
| Part 2, Cohorts 1 & 2: Time to CR |  |  | 
| Part 2, Cohorts 1 & 2: Time to response (PR or CR) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Cancer