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

NCT00754494 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02984UCI06-8-01N01CN35160CDR0000614277
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Change in ACF pERK Levels

  Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.

  From baseline to post-treatment (up to 30 days)

Secondary Outcomes (12)

• Change in EGF-inducible Markers - pEGFR in Normal Mucosa

  From baseline to post-treatment (up to 30 days)

• Change in EGF-inducible Markers - Total EGFR in Normal Mucosa

  From baseline to post-treatment (up to 30 days)

• Change in EGF-inducible Markers - pEGFR in ACF

  From baseline to post-treatment (up to 30 days)

• Change in EGF-inducible Markers - Total EGFR in ACF

  From baseline to post-treatment (up to 30 days)

• ACF: Normal Mucosa pERK Ratio

  Up to day 30

Study Arms (3)

Erlotinib Hydrochloride (25 mg)

EXPERIMENTAL

Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.

Drug: erlotinib hydrochloride; Other: placebo; Other: laboratory biomarker analysis

Erlotinib Hydrochloride (50 mg)

EXPERIMENTAL

Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.

Drug: erlotinib hydrochloride; Other: placebo; Other: laboratory biomarker analysis

Erlotinib Hydrochloride (100 mg)

EXPERIMENTAL

Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.

Drug: erlotinib hydrochloride; Other: placebo; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given PO

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

Erlotinib Hydrochloride (100 mg); Erlotinib Hydrochloride (25 mg); Erlotinib Hydrochloride (50 mg)

placebo OTHER

Given PO

Also known as: PLCB

Erlotinib Hydrochloride (100 mg); Erlotinib Hydrochloride (25 mg); Erlotinib Hydrochloride (50 mg)

laboratory biomarker analysis OTHER

Correlative studies

Erlotinib Hydrochloride (100 mg); Erlotinib Hydrochloride (25 mg); Erlotinib Hydrochloride (50 mg)

Eligibility Criteria

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

You may qualify if:

• Participants with one or more of the following criteria will be eligible to participate:
• History of Stage I-III colorectal cancer, not treated in the past 6 months with no anticipated treatment in the next 3 months
• Adenoma ≥ 1 cm in size
• or more adenomas (of any size) removed at one colonoscopy within past 6 years
• Sessile serrated adenoma ≥ 5 mm in size
• Adenoma (of any size) with villous features (villous, tubulovillous)
• Adenoma (of any size) with high grade dysplasia
• Participants are eligible for randomization into the treatment phase of the trial if they are found to have ≥ 4 ACFs at either baseline colonoscopy or baseline flexible sigmoidoscopy
• Blood tests at screening which meet the following criteria:
• WBC \> 3000/mm\^3
• Platelets \> 100,000/mm\^3
• Hemoglobin \> 10g/dl
• Plasma creatinine of \< 1.6mg/dl
• Total bilirubin \< 1.5 x the upper limit of normal
• Serum ALT \< 1.5 x the upper limit of normal

You may not qualify if:

• History of Inflammatory Bowel Disease (IBD)
• History of interstitial lung disease or chronic lung disease
• Smoking within the past 3 months
• Increased bleeding risk from rectal biopsy (Patients receiving aspirin or plavix can be enrolled)
• Patients receiving warfarin or coumadin
• Uncontrollable diarrhea of any cause
• Patients, including rectal cancer patients, that have received prior radiation to the rectum or pelvis
• Participants taking a known significant CYP 3A4 inducer or inhibitor; known significant inducers/inhibitors include: amprenavir, aprepitant, atazanavir, carbamazepine, clarithromycin, conivaptan, diltiazem, darunavir/ritonavir, dronedarone, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenytoin, posaconazole, rifampin, ritonavir, St. John's wort, saquinavir, telithromycin, tipranavir/ritonavir, verapamil, voriconazole
• Women who are pregnant or breast-feeding
• Active keratoconjunctivitis, or corneal surgery in the past three weeks
• Any medical or psychosocial condition that could jeopardize the subject's participation in and compliance to the study
• Participants who are taking any other investigational pharmaceutical agents
• Previous history of sensitivity to erlotinib, Iressa, or Erbitux, such as a rash that is uncontrollable by topical steroids and/or antibiotics

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Adenomatous Polyps; Colonic Neoplasms; Rectal Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; 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

Results Point of Contact

• Title: Dr. Timothy R. Morgan
• Organization: University of California, Irvine

timothy.morgan@va.gov

562-826-5756

Study Officials

• Timothy Morgan

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: September 1, 2013
• Last Updated: January 6, 2015
• Results First Posted: January 6, 2015

Record last verified: 2014-03

Locations

US (3)