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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00425035
First received: January 18, 2007
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Advanced Renal Cell Carcinoma
Drug: Panitumumab (ABX-EGF)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-part, Multiple Dose Clinical Trial Evaluating the Safety and Effectiveness of ABX-EGF in Patients With Renal Carcinoma

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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:
  • 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)

Estimated Enrollment: 115
Study Start Date: February 2003
  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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425035

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00425035     History of Changes
Obsolete Identifiers: NCT00036530
Other Study ID Numbers: 20020374, Abgenix protocol No. ABX-0303, Immunex protocol No. 054.0003
Study First Received: January 18, 2007
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Renal Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014