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

NCT00470535 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000543406RPCI-I-87106
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion

  Every cycle for up to 52 weeks

Secondary Outcomes (5)

• Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria

  After every cycle

• Median Overall Survival

  After every cycle

• 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

• Correlation of Smoking Status With Overall Survival

  Every 3 weeks

• 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

Study Arms (1)

Arm 1 - Oral Erlotinib hydrochloride

EXPERIMENTAL

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

Drug: erlotinib hydrochloride; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Oral

Arm 1 - Oral Erlotinib hydrochloride

immunohistochemistry staining method OTHER

Correlative Study

Arm 1 - Oral Erlotinib hydrochloride

laboratory biomarker analysis OTHER

Correlative Study

Arm 1 - Oral Erlotinib hydrochloride

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Immunohistochemistry

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Limitations and Caveats

This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Renuka Iyer, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: May 3, 2007
• First Posted: May 7, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: September 1, 2010
• Last Updated: February 23, 2017
• Results First Posted: December 10, 2014

Record last verified: 2017-01

Locations

US (1)