Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00032110
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    Given orally
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or metastatic colorectal cancer.

Key Dates

First listed
Jan 27, 2003
Start date
Jan 31, 2002
Status verified
Jan 2013
Primary completion
May 31, 2007
Completion
May 31, 2007

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (erlotinib hydrochloride)
    Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a CR receive 2 additional courses after CR is confirmed.

Primary Outcome Measure

Objective response or disease stabilization [ Time Frame: Up to 5 years ]

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