A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer
OBJECTIVES:
- 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
following:
- 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
PRIOR CONCURRENT THERAPY:
- 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:
Interventional
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:
Yes
Principal Investigator
Nipun B. Merchant
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
VICC GI 0466
NCT ID:
NCT00467116
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
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
