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

Phase 2
Not Enrolling
Advanced Renal Cell Carcinoma

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Trial Information

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

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:

1. 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%

2. 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

- Adequate hematologic data, as follows:

1. ANC > 1.5 x 109/L

2. Platelet count > 100x 109/L

- Adequate renal function, as follows:

1. Creatinine < or = 2.2mg/dL

- Adequate hepatic function, as follows:

1. Alkaline phosphatase < or = 3x ULN

2. AST < or = 3x ULN

3. ALT < or = 3x ULN

4. 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 2, Cohort 1: Efficacy: Tumor response rate (CR or PR) measured at 8 weeks

Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • Renal Cancer
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms