Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225784
• Other study ID #: DMS 0432
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2005
• Last updated: July 10, 2014
• Start date: February 2005
• Est. completion date: September 2012

Study information

• Verified date: October 2011
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.

Description:

The study treatment for this protocol is

• Loading dose of Cetuximab 400 mg/m2

• Weekly Cetuximab 250 mg/m2

• Bi-weekly Gemcitabine 50 mg/m2

• Daily Radiation for 28 fractions

• CT scan four weeks after completion of treatment

• Evaluation by surgeon for resectability

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic proof of pancreatic adenocarcinoma

• Clinical stage I, II, or III disease

• Radiographically measurable disease

• Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry

• Signed protocol consent

• Karnofsky performance status of at least 70%

• Age > or = to 18 years

• Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment.

• Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul.

• Creatinine < 1.5 x upper limit of normal (ULN)

• Bilirubin < 1.5 x ULN; AST < 2.5 x ULN.

Exclusion Criteria:

• Acute hepatitis or known HIV

• Active or uncontrolled infection

• Significant history of cardiac disease

• Prior therapy which affects or targets the EGF pathway

• Prior severe infusion reaction to a monoclonal antibody

• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents

• Any previous chemotherapy or abdominal or pelvic radiotherapy

• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years.

• Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Cetuximab/Gemcitabine
Once weekly Cetuximab, twice weekly Gemcitabine for six weeks

Procedure:
• Radiotherapy
Daily radiotherapy for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response of Tumor by RECIST 1.0 Criteria	Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.	one month post-therapy	No
Secondary	Number of Participants Assessed for Adverse Events	Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0	Participants were followed during treatment and for 30 days after completion of treatment	Yes
Secondary	Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy	Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).	1 month after completion of treatment	No
Secondary	Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.	Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.	One month post-therapy	No
Secondary	Disease-Free Survival After Therapy	Time to disease progression after therapy.	Five years post treatment	No
Secondary	Overall Length of Survival After Therapy	Length of survival after therapy in all participants enrolled.	Five years post treatment	No
Secondary	Pattern of Failure After Therapy	Local recurrence, distant recurrence, or both.	Five years post treatment	No