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A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy


Inclusion Criteria:



- Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by
tissue biopsy)

- Metastatic colorectal carcinoma

- Eastern Cooperative Oncology Group of 0, 1 or 2

- Documented evidence of disease progression during, or following treatment, with
fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal
cancer

- Radiographic documentation of disease progression during or within 6 months following
the most recent chemotherapy regimen is required

- Bidimensionally measurable disease

- Tumor expressing EGFr by immunohistochemistry

- At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal
cancer

- Adequate hematologic, renal and hepatic function

Exclusion Criteria:

- Symptomatic brain metastases requiring treatment

- Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence
of interstitial pneumonitis or pulmonary fibrosis

- Use of systemic chemotherapy or radiotherapy within 30 days before enrollment

- Prior epidermal growth factor receptor targeting agents

- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor
small molecules and biologics of short (less than 1 week) serum half-life within 30
days before enrollment, or prior experimental or approved proteins with longer serum
half-life (e.g., AvastinTM) within 6 weeks before enrollment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Duration of Response

Outcome Description:

Duration of confirmed objective tumor response (complete or partial), centrally assessed per modified WHO criteria

Outcome Time Frame:

Until disease progression (median 7 weeks)

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20030167

NCT ID:

NCT00083616

Start Date:

March 2004

Completion Date:

December 2008

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • EGFr
  • Clinical Trial
  • Panitumumab
  • ABX-EGF
  • Immunex
  • Metastatic Cancer
  • Vectibix
  • Abgenix
  • Amgen
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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