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A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer


- Determine the maximum tolerated dose of gemcitabine hydrochloride when administered
with cetuximab and radiotherapy in patients with unresectable locally advanced
pancreatic or periampullary region cancer.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride.

Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-7 and gemcitabine
hydrochloride IV over 15-40 minutes once weekly in weeks 2-7. Patients also undergo
radiotherapy 5 days a week in weeks 2-7. Treatment continues in the absence of disease
progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed for 30 days and then every 3
months thereafter.

PROJECTED ACCRUAL: A total of 12-30 patients will be accrued for this study.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the pancreas (head, body, or tail) or
periampullary region, meeting both of the following criteria:

- Unresectable disease

- Locally advanced disease

- Measurable or evaluable disease by CT scan or MRI

- No evidence of metastatic disease outside of the planned irradiation field

- ECOG performance status 0-2

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 8.5 g/dL

- AST and ALT ≤ 5 times upper limit of normal

- Bilirubin ≤ 2.0 mg/dL

- Creatinine ≤ 2.0 mg/dL

- No clinical indication of compromised function of nonirradiated kidney

- No secondary malignancies within the past 5 years except for resected nonmelanoma
skin cancer or carcinoma in situ of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

Exclusion Criteria:

- No acute hepatitis

- No known HIV infection

- No other active or uncontrolled infection

- No significant history of uncontrolled cardiac disease, including any of the

- Hypertension

- Unstable angina

- Myocardial infarction within the past 6 months

- Congestive heart failure

- Cardiomyopathy with decreased ejection fraction

- No prior severe infusion reaction to a monoclonal antibody


- No prior radiotherapy to planned field of treatment

- No prior therapy that specifically and directly targets EGFR pathway

- At least 14 days since prior surgery or biopsy

- At least 28 days since prior bypass procedures

- More than 5 years since prior and no other concurrent chemotherapy

- No other concurrent investigational agent

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

Weekly and 4 weeks after last dose of radiation

Safety Issue:


Principal Investigator

Nipun B. Merchant

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:

VICC GI 0466



Start Date:

October 2005

Completion Date:

October 2007

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage II pancreatic cancer
  • recurrent pancreatic cancer
  • Pancreatic Neoplasms



Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838