Phase II Trial of Erlotinib in Advanced Pancreatic Cancer

NCT00497224 | Completed Phase 2 DMC

• 1 other identifier: OSI-Tar-725
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

Brief Summary

This is an open-label, multi-center phase II study of erlotinib in patients with metastatic or locally advanced, unresectable pancreatic cancer who have received up to one line of gemcitabine based chemotherapy.

Conditions

Cancer; Pancreas

Keywords

Pancreatic Cancer; Pancreatic Carcinoma; Pancreas; Adenocarcinoma; Erlotinib; Tarceva; OSI-774; Phase II

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Measured by the rate of disease control (objective response plus prolonged stable disease), in patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma.

  Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (2 months) with CT scan

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of Erlotinib]

  Assessed every cycle (month)

• Tolerability of Erlotinib Dose Escalation

  assessed cycle 1, day 28, then every cycle (month)

Study Arms (1)

Erlotinib

EXPERIMENTAL

Eligible patients will receive erlotinib 150mg PO daily, with dose escalation occurring as tolerated.

Drug: Erlotinib

Interventions

Erlotinib DRUG

Erlotinib starting at 150 mg PO (by mouth) daily. Dose may increase or decrease by the study doctor as per protocol (study plan).

Also known as: TARCEVA, OSI-774

Erlotinib

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed pancreatic carcinoma that is locally advanced, unresectable or metastatic.
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
• Previous therapy:
• Surgery: Previous surgery is permissible. Patients must be \> 4 weeks from any major surgery.
• Chemotherapy: Patients may have received up to 1 prior line of gemcitabine based systemic therapy (single agent or combination therapy) for locally advanced or metastatic disease. Prior therapy with inhibitors of angiogenesis is permitted. All toxicities must be resolved to \< Grade 1 (CTCAE v 3.0) and the last dose must have been given at least 4 weeks prior to randomization.
• Patients may also have received prior 5 FU (+/- folinic acid) or gemcitabine given concurrently with radiation as a "radiation sensitizer". All toxicities must be resolved and the last dose of chemotherapy must have been given at least 4 weeks prior to randomization.
• Radiation: Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented (either locally or systemically), all toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization.
• Age \>18 years. Because no dosing or adverse event data are currently available on the use of erlotinib in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
• Life expectancy of greater than or equal to 3 months.
• ECOG performance status \<2.
• Patients must have normal organ and marrow function as defined below:
• Leukocytes \>/= 3,000/mcL
• Absolute neutrophil count \>/= 1,000/mcL
• Platelets \>/= 100,000/mcL
• Total bilirubin \</= 1.5 UNL

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients receiving any other investigational agents concurrently are ineligible.
• Prior therapy with inhibitors of the EGFR (eg. cetuximab, EMD 72000, panitumumab, gefitinib, erlotinib) or multitargeted agents that inhibit EGFR (eg. ZD6474, AEE788).
• Patients with allergies to or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to erlotinib.
• Patients with greater than grade 1 diarrhea at baseline. Patients with pancreatic cancer often have diarrhea due to pancreatic insufficiency, so a trial of pancreatic enzymes may be warranted to reduce baseline diarrhea.
• PT INR \>1.5 unless the patient is on full-dose warfarin.
• Patients with any condition that impairs their ability to swallow and retain pills
• Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because erlotinib has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib, breastfeeding should be discontinued if the mother is treated with erlotinib.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with erlotinib. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• OSI Pharmaceuticals: collaborator

Study Sites (5)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Renouf DJ, Tang PA, Hedley D, Chen E, Kamel-Reid S, Tsao MS, Tran-Thanh D, Gill S, Dhani N, Au HJ, Wang L, Moore MJ. A phase II study of erlotinib in gemcitabine refractory advanced pancreatic cancer. Eur J Cancer. 2014 Jul;50(11):1909-15. doi: 10.1016/j.ejca.2014.04.008. Epub 2014 May 21.

  PMID: 24857345 DERIVED

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms; Adenocarcinoma

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

• Malcolm Moore, MD

  Drug Development Program, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2013
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

CA (5)