Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

NCT00032110 | Completed Phase 2

• 6 other identifiers: NCI-2012-02459CDR0000069258PHL-003NCI-53785378N01CM17107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective response or disease stabilization

  Up to 5 years

Secondary Outcomes (1)

• Molecular changes with therapy

  Up to 5 years

Study Arms (1)

Treatment (erlotinib hydrochloride)

EXPERIMENTAL

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; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (erlotinib hydrochloride)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (erlotinib hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (erlotinib hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Amit Oza

  Princess Margaret Hospital Phase 2 Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: April 15, 2015

Record last verified: 2013-01

Locations

CA (1)