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

Amgen0 sites115 target enrollmentFebruary 2003

ConditionsAdvanced Renal Cell Carcinoma

DrugsPanitumumab (ABX-EGF)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Advanced Renal Cell Carcinoma
Sponsor: Amgen
Enrollment: 115
Primary Endpoint: Part 2, Cohort 1: Efficacy: Tumor response rate (CR or PR) measured at 8 weeks
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

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.

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

Outcomes

Primary Outcomes

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

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)