Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00470535
• Other study ID #: CDR0000543406
• Secondary ID: RPCI-I-87106
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2007
• Last updated: December 3, 2014
• Start date: January 2007
• Est. completion date: September 2010

Study information

• Verified date: December 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV pancreatic cancer.

Description:

OBJECTIVES:

Primary

• Determine the progression-free survival (PFS) of patients with stage III or IV adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or second-line therapy.

Secondary

• Determine the proportion of patients with a radiological response to this drug.

• Determine the overall survival of these patients.

• Determine the effect of this drug on quality of life in these patients.

• Correlate expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 in baseline tumor blocks and presence of K-ras mutations in baseline tumor biopsy specimens with response to this drug.

• Correlate smoking status with PFS in patients treated with this drug.

• Collect serum samples before, during, and after therapy for future serum proteomic studies and for development of profiles of responders to this drug.

OUTLINE: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Patients complete a questionnaire about their smoking status at baseline. Patients also complete questionnaires about their quality of life every three weeks during study therapy and after completion of study therapy.

Blood samples are collected from patients at baseline and periodically during study for future serum proteomic research and for development of profiles of responders to erlotinib hydrochloride therapy. Paraffin-embedded tumor tissue from diagnostic tumor biopsies is assessed at baseline for expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 by immunohistochemical analysis. Tissue from surgical specimens in patients with prior resection is assessed for K-ras mutations by K-ras analysis.

After completion of study therapy, patients are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Locally advanced inoperable or metastatic disease (stage III or IV disease)

• No more than 1 prior systemic therapy

• Patients who have not received 1 prior systemic therapy must meet 1 of the following criteria:

• Ineligible for or refused chemoradiotherapy AND has stage III disease

• Ineligible for or refused gemcitabine hydrochloride-based chemotherapy AND has stage IV disease

• No brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 3 months

• WBC > 3,000/mm³

• ANC > 1,500/mm³

• Platelet count > 100,000/mm³

• Bilirubin = 2 mg/dL

• AST and ALT = 2.5 times upper limit of normal (ULN) (= 5 times ULN in patients with documented liver metastases)

• Creatinine < 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study therapy

• No uncontrolled comorbid illness that is likely to increase toxicity of the study drug or to interfere with toxicity evaluation

• No known allergy to the study drug or its excipients

• No symptomatic interstitial pulmonary disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Prior adjuvant therapy allowed provided it was completed at least 28 days prior to study entry

• No prior EGFR-inhibitor

• No concurrent drugs that are known to be strong inducers or inhibitors of the CYP450 enzyme system

• No concurrent Hypericum perforatum (St. John's wort)

• No concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• erlotinib hydrochloride
Oral

Other:
• immunohistochemistry staining method
Correlative Study
• laboratory biomarker analysis
Correlative Study

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		Every cycle	No
Secondary	Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria		After every cycle	No
Secondary	Median Overall Survival		After every cycle	No
Secondary	Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy		Every 3 weeks	No
Secondary	Correlation of Smoking Status With Overall Survival		Every 3 weeks	No
Secondary	Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade		At Baseline	No