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

NCT00425035 | Completed Phase 2

• 3 other identifiers: 20020374Abgenix protocol No. ABX-0303Immunex protocol No. 054.0003
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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

Keywords

Renal Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Interventions

Panitumumab (ABX-EGF) DRUG

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. Creatinine \< or = 2.2mg/dL

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• 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.

  PMID: 15210739 RESULT

Related Links

• FDA-approved Drug Labeling
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic 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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 22, 2007
• Study Start: February 1, 2003
• Last Updated: May 13, 2013

Record last verified: 2013-05