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Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: March 8, 2002
Last updated: April 14, 2015
Last verified: January 2013
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.

Condition Intervention Phase
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Drug: erlotinib hydrochloride
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of OSI-774 in Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response or disease stabilization [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:
  • Molecular changes with therapy [ Time Frame: Up to 5 years ]
    Will be examined using logistic regression or Fisher's exact tests as appropriate.

Enrollment: 30
Study Start Date: January 2002
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


I. Determine the efficacy of erlotinib, in terms of response rate and duration of stable disease, in patients with recurrent or metastatic colorectal cancer.

II. Determine the toxicity of this drug in these patients. III. Determine the time to progression and response duration in patients treated with this drug.

IV. Determine the relationships between clinical, pharmacokinetic, and pharmacodynamic effects of this drug in these patients.

V. Correlate baseline and post-treatment levels of epidermal growth factor receptor, its downstream signaling components, markers of angiogenesis, and apoptosis in tumor and skin biopsies with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study.

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

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4-8 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not curable with conventional therapy

    • Recurrent or metastatic disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques
    • At least 10 mm by spiral CT scan
    • Target lesion must not be in a previously irradiated field unless progression of this lesion has been documented
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • WBC at least 1,500/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST or ALT no greater than 3 times ULN (5 times ULN if liver metastases present)
  • Creatinine no greater than 1.25 times ULN
  • Creatinine clearance at least 50 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
  • No active peptic ulcer disease
  • No unresolved complete or subacute bowel obstruction
  • No severe enteropathy that would interfere with absorption of study drug
  • No abnormalities of the cornea:

    • Dry eye syndrome or Sjogren's syndrome
    • Congenital abnormality (e.g., Fuch's dystrophy)
    • Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
    • Abnormal corneal sensitivity test (Schirmer test or similar tear production test)
  • No significant traumatic injury within the past 21 days
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study
  • No other concurrent uncontrolled illness that would preclude study
  • No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No more than 1 prior chemotherapy regimen for metastatic disease with either fluorouracil (5-FU) and oxaliplatin or 5-FU and a topoisomerase inhibitor (e.g., irinotecan), OR 5-FU (or other single-agent fluoropyrimidine, such as capecitabine) followed by irinotecan for advanced disease
  • Prior adjuvant chemotherapy allowed
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 3 weeks since prior major surgery
  • No prior surgical procedures affecting absorption
  • No prior epidermal growth factor receptor-targeting therapy
  • No other concurrent investigational therapies
  • No other concurrent anticancer therapy
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No concurrent warfarin

    • Low molecular weight heparin allowed
  Contacts and Locations
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Please refer to this study by its identifier: NCT00032110

Canada, Ontario
Princess Margaret Hospital Phase 2 Consortium
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Amit Oza Princess Margaret Hospital Phase 2 Consortium
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00032110     History of Changes
Other Study ID Numbers: NCI-2012-02459
NCI-2012-02459 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHL-003 ( Other Identifier: Princess Margaret Hospital Phase 2 Consortium )
5378 ( Other Identifier: CTEP )
N01CM17107 ( US NIH Grant/Contract Award Number )
Study First Received: March 8, 2002
Last Updated: April 14, 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017