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Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

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Trial Information


Inclusion Criteria:



- Signed and dated, institutional review board (IRB) or independent ethics committee
(IEC)-approved informed consent form before any protocol-specific screening
procedures

- Previous histologic diagnosis of adenocarcinoma of the colon or rectum

- EGFR expression by immunohistochemical analysis (must be > or = 20% positive tumor
cells in prior tumor biopsy specimens)

Exclusion Criteria:

- Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents
within 4 weeks of treatment day 1 (6 weeks if the previous regimen included
mitomycin or nitrosoureas).

- Prior epidermal growth factor receptor-targeting therapy

- Known central nervous system (CNS) metastases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3095A1-200

NCT ID:

NCT00072748

Start Date:

Completion Date:

October 2004

Related Keywords:

  • Colorectal Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Advanced Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Neoplasms, Colorectal
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Rectal Neoplasms

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