NCT00754494

Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma

A Phase IIa Randomized, Double-Blind Trial of Erlotinib in Inhibiting EGF Receptor Signaling in Aberrant Crypt Foci of the Colon

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial is studying how well erlotinib hydrochloride works in treating patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming back

Detailed description

PRIMARY OBJECTIVES: I. To test the hypothesis that erlotinib (erlotinib hydrochloride) doses as low as 25 mg will decrease aberrant crypt foci (ACF) phosphorylated extracellular signal-regulated kinases (pERK) levels from baseline (pre) to post erlotinib treatment. SECONDARY OBJECTIVES: I. To test the hypothesis that additional epidermal growth factor (EGF) inducible biomarkers will decrease from baseline (pre) to post treatment with erlotinib 25 mg, 50 mg or 100 mg orally (PO) once daily (QD) therapy. II. To determine the mean decrease from baseline of the ACF: normal mucosa pERK ratio pre and post 8-30 days of erlotinib. III. To determine erlotinib concentration in plasma and colorectal tissue at 25 mg, 50 mg and 100 mg doses after 8-30 days of therapy. IV. To determine the incidence of rash, diarrhea and other side effects of low dose erlotinib. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD. ARM II: Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD. ARM III: Patients receive 25 mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD. In all arms, treatment continues for 8-30 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 to 9 weeks.

Conditions

• Adenomatous Polyp
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage I Colon Cancer
• Stage I Rectal Cancer
• Stage IIA Colon Cancer
• Stage IIA Rectal Cancer
• Stage IIB Colon Cancer
• Stage IIB Rectal Cancer
• Stage IIC Colon Cancer
• Stage IIC Rectal Cancer
• Stage IIIA Colon Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Colon Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Colon Cancer
• Stage IIIC Rectal Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given PO
OTHER	placebo	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-10-01
• Completion: 2013-09-01
• First posted: 2008-09-18
• Last updated: 2015-01-06
• Results posted: 2015-01-06

Locations

3 sites across 1 country: United States