Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

Dartmouth Health

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Cetuximab/Gemcitabine; Procedure: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00225784

DMS 0432

Details and patient eligibility

About

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

Full 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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Cetuximab, Gemcitabine, RT

Experimental group

Description:

weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy

Treatment:

Procedure: Radiotherapy

Drug: Cetuximab/Gemcitabine