Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

NCT00837876 | Completed Phase 2 Results DMC

• 3 other identifiers: VICC GI 0815P30CA068485VU-VICC-GI-0815
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 6

Brief Summary

RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with pancreatic cancer that cannot be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Progression-free Survival

  Number of patients with progression-free survival at 8 weeks

  at 8 weeks

Secondary Outcomes (3)

• Response Rate

  at 4 months

• Number of Patients With Progression-free Survival

  at 4 months

• Number of Patients With Worst Grade Toxicities

  every 4 weeks and every 8 weeks in follow-up to resolution of toxicity

Study Arms (1)

Treatment

EXPERIMENTAL

Sorafenib + Erlotinib

Drug: Sorafenib; Drug: Erlotinb

Interventions

Sorafenib DRUG

400 mg taken by mouth 1 time per day.

Treatment

Erlotinb DRUG

150 mg taken by mouth 1 time per day.

Treatment

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Microscopically confirmed diagnosis of pancreatic adenocarcinoma * Unresectable disease * No neuroendocrine tumors or cystadenocarcinoma * Measurable or evaluable disease by RECIST criteria * No known brain metastases * Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement) * Creatinine ≤ 1.5 times ULN * INR \< 1.5 or PT/PTT normal unless patients are receiving anticoagulation treatments * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective barrier contraception before, during, and for at least 6 months after completion of study treatment * Able to swallow whole pills * No patients who currently smoke * No cardiac disease, including any of the following: * NYHA class III-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New-onset angina (began within the past 3 months) * Myocardial infarction within the past 6 months * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg despite optimal medical management * No arterial thrombotic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months * No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 in the past 4 weeks * No other hemorrhage/bleeding event ≥ CTCAE grade 3 in the past 4 weeks * No significant traumatic injury in the past 4 weeks * No known untreated malabsorption problem (e.g., ulcerative colitis, Crohn's disease) * No known HIV positivity or chronic hepatitis B or C * No known or suspected allergy to sorafenib tosylate or erlotinib hydrochloride * No active clinically serious infection \> CTCAE grade 2 * No serious non-healing wound, ulcer, or bone fracture * No evidence or history of bleeding diathesis or coagulopathy (except for cancer-related blood clots) * No dermatitis ≥ CTCAE grade 2 at baseline * No patients who currently smoke PRIOR CONCURRENT THERAPY: * No prior treatment with antiangiogenics (e.g., bevacizumab, thalidomide, marimastat, interferon alfa, vatalanib, vandetanib, ZD6126, sorafenib, semaxanib, sunitinib, axitinib) * No more than one line of prior therapy for metastatic disease * More than 4 weeks since prior major surgery or open biopsy * No concurrent strong CYP34A inhibitors or inducers * Concurrent warfarin or heparin allowed with the approval of the principal investigator

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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Purchase Cancer Group - Paducah

Paducah, Kentucky, 42002, United States

Location

Erlanger Cancer Center at Erlanger Hospital - Baroness

Chattanooga, Tennessee, 37403, United States

Location

Baptist Regional Cancer Center at Baptist Riverside

Knoxville, Tennessee, 37901, United States

Location

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Jordan Berlin, MD
• Organization: Vanderbilt-Ingram Cancer Center

jordan.berlin@vanderbilt.edu

615-343-4128

Study Officials

• Jordan D. Berlin, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Clinical Director, GI Oncology Program; Director, Phase I Program; Medical Director, Clinical Trials Shared Resources; Medical Oncologist

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2012
• Last Updated: June 25, 2014
• Results First Posted: September 28, 2012

Record last verified: 2013-07

Locations

US (6)