Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Recurrent Rectal Cancer Clinical Trial

Official title:

A Phase II Study of OSI-774 in Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032110
• Other study ID #: NCI-2012-02459
• Secondary ID: NCI-2012-02459CD
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2002
• Last updated: April 14, 2015
• Start date: January 2002
• Est. completion date: May 2007

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVES:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• erlotinib hydrochloride
Given orally

Other:
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital Phase 2 Consortium	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response or disease stabilization		Up to 5 years	No
Secondary	Molecular changes with therapy	Will be examined using logistic regression or Fisher's exact tests as appropriate.	Up to 5 years	No