Clinical trial NCT00225784: Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
Official title: A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Stage I, II, III pancreatic adenocarcinoma
Radiographically measurable disease
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response of Tumor by RECIST 1.0 Criteria
timeFrame: one month post-therapy
Secondary outcomes:
measure: Number of Participants Assessed for Adverse Events
timeFrame: Participants were followed during treatment and for 30 days after completion of treatment
measure: Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
timeFrame: 1 month after completion of treatment
measure: Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
timeFrame: One month post-therapy
measure: Disease-Free Survival After Therapy
timeFrame: Five years post treatment
measure: Overall Length of Survival After Therapy
timeFrame: Five years post treatment
measure: Pattern of Failure After Therapy
timeFrame: Five years post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: J Marc Pipas, MD
role: PRINCIPAL_INVESTIGATOR
References: