Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer

NCT00696696 | Completed Phase 2 Results DMC

• 1 other identifier: NYU 06-882
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

This study tests the combination of two targeted therapies,along with chemotherapy treatment in the treatment of pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Pancreatic adenocarcinoma; metastatic; EGRF inhibitor; targeted therapy; combined cancer therapy; kinase inhibitor; VEGF-R inhibitor

Outcome Measures

Primary Outcomes (1)

• 4-month Progression Free Survival (PFS) Rate

  The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles.

  4 months

Secondary Outcomes (2)

• Objective Response Rate

  up to 1 year

• Median Overall Survival (mOS)

  up to 2 years

Study Arms (1)

Combination GES

EXPERIMENTAL

Combination of Gemcitabine, Erlotinib, and Sorafenib

Drug: Gemcitabine; Drug: Erlotinib; Drug: Sorafenib

Interventions

Gemcitabine DRUG

1000 mg/m\^2, intravenous, Days 1, 8, 15 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.

Also known as: Gemzar

Combination GES

Erlotinib DRUG

150 mg, taken orally, once a day, Days 1-28 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.

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

Combination GES

Sorafenib DRUG

400 mg, taken orally, twice a day, Days 1-28 for every 28-day cycle. In the absence of disease progression or toxicity, a patient may continue to receive gemcitabine, erlotinib, and sorafenib until disease progression.

Also known as: Nexavar, BAY 43-9006

Combination GES

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed pancreatic adenocarcinoma not amenable to curative treatment with surgery. Patients with locally advanced disease must have disease that extends outside the boundaries of a standard radiation port.
• Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST). This requires 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. Pleural effusions and ascites are not considered measurable lesions.
• No prior cytotoxic chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, however at least 6 months must have elapsed from administration of the last dose of chemotherapy or radiotherapy.
• No prior therapy with a VEGF, EGFR, or multi-targeted kinase inhibitor.
• Age \>18 years.
• Life expectancy of greater than 3 months.
• Eastern Cooperative Oncology Group performance status 0-1.
• Normal organ and marrow function as defined below:
• White blood cells (WBC) \>3,000/µl
• Absolute neutrophil count \>1,500/µl
• Platelets \>100,000/µl
• Total bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)
• Transaminases(SGOT/ SGPT)
• without liver mets ≤ 2.5 x institutional ULN
• with liver mets ≤ 5 x institutional ULN

You may not qualify if:

• No prior treatment with bevacizumab, cetuximab, or erlotinib. Prior gemcitabine in the adjuvant setting completed more than six months previously will be allowed.
• No other investigational agents.
• No central nervous system (CNS) disease, including primary brain tumors, brain metastasis, or history of a cerebro-vascular accident (CVA) or transient ischemic attack (TIA) within 6 months of starting therapy.
• No allergic reactions to compounds similar to erlotinib or sorafenib.
• Because an increased risk of bleeding may occur following sorafenib administration, no patients will be allowed with a history of bleeding diathesis or coagulopathy. No grade \> 2 pulmonary hemorrhage or \> grade 3 other hemorrhage within 28 days of beginning therapy.
• No recent invasive procedures defined as follows: Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 of therapy
• No Patients with clinically significant cardiovascular disease, defined as:
• Uncontrolled hypertension
• Myocardial infarction \< 6 months prior to registration and new onset angina within 3 months (controlled stable angina acceptable)
• New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
• Grade II or greater peripheral vascular disease
• No serious or non-healing wound, ulcer, or bone fracture.
• No active infection requiring parental antibiotics.
• No currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix.
• If a patient is on full-dose anticoagulants (warfarin or low molecular weight heparins are allowed), the following criteria should be met for enrollment: they must have a therapeutic INR, no greater than 3, on a stable dose of warfarin.

Sponsors & Collaborators

• NYU Langone Health: lead
• Bayer: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (3)

Desert Regional Medical Center

Palm Springs, California, 92262, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

New York University Cancer Center

New York, New York, 10016, United States

Location

Related Publications (2)

• Kindler HL, K. A. Bylow, H. S. Hochster, G. Friberg, K. Micetich, G. Locker, M. Kozloff, M. Moore, W. Sun, E. E. Vokes, and University Of Chicago Phase II Consortium. A randomized phase II study of bevacizumab (B) and gemcitabine (G) plus cetuximab (C) or erlotinib (E) in patients with advanced pancreatic cancer: A preliminary analysis. J. Clin. Oncol (Meeting Abstracts) June 2006, vol. 24 no. 18_suppl 4040

  BACKGROUND

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

  PMID: 10655437 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; Erlotinib Hydrochloride; Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: Deirdre Cohen, MD
• Organization: NYU Cancer Institute

deirdre.cohen@nyumc.org

212-731-5656

Study Officials

• Deirdre Cohen, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 11, 2008
• First Posted: June 13, 2008
• Study Start: September 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: June 1, 2013
• Last Updated: June 30, 2016
• Results First Posted: December 21, 2011

Record last verified: 2016-05

Locations

US (3)