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

NCT ID: NCT00425035

Last Updated: 2013-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28

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.

Conditions

Advanced Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Panitumumab (ABX-EGF)

Intervention Type: DRUG

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:

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 regisration.
• 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

• 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

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)

• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Rowinsky EK, Schwartz GH, Gollob JA, Thompson JA, Vogelzang NJ, Figlin R, Bukowski R, Haas N, Lockbaum P, Li YP, Arends R, Foon KA, Schwab G, Dutcher J. Safety, pharmacokinetics, and activity of ABX-EGF, a fully human anti-epidermal growth factor receptor monoclonal antibody in patients with metastatic renal cell cancer. J Clin Oncol. 2004 Aug 1;22(15):3003-15. doi: 10.1200/JCO.2004.11.061. Epub 2004 Jun 21.

Reference Type: RESULT

PMID: 15210739 (View on PubMed)

Related Links

http://www.vectibix.com/

FDA-approved Drug Labeling

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_954_AMG_954_20020374.pdf

To access clinical trial results information click on this link

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

Abgenix protocol No. ABX-0303

Identifier Type: -

Identifier Source: secondary_id

Immunex protocol No. 054.0003

Identifier Type: -

Identifier Source: secondary_id

20020374

Identifier Type: -

Identifier Source: org_study_id

NCT00036530

Identifier Type: -

Identifier Source: nct_alias