Back to resultsPhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cetuximab
gemcitabine hydrochloride
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer, recurrent pancreatic cancer
Eligibility Criteria
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
Sites / Locations
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapeutic Intervention
Arm Description
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
Secondary Outcome Measures
Dose-limiting toxicity
Toxicity
Tumor response rate
Full Information
NCT ID
NCT00467116
First Posted
April 25, 2007
Last Updated
May 16, 2012
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00467116
Brief Title
PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca
Official Title
A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Gemcitabine and cetuximab may make tumor cells more sensitive to radiation therapy. Giving gemcitabine together with cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with cetuximab and radiation therapy in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer, recurrent pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Intervention
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
400mg/m2 initial dose week 1; followed by 250mg/m2/weekly starting week 2 with gemcitabine at fixed dose rate (10 mg/m2/min) + XRT. Cetuximab will start 1 week prior to all other treatment.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
Gemzar
Intervention Description
Dose Level Gemcitabine dose Gemcitabine infusion
-1 150mg/m2 15 Minutes 0 200mg/m2 20 minutes
300mg/m2 30 minutes
400mg/m2 40 minutes
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
50.4 Gy, 28 fractions, 5.5 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to encompass gross disease with a margin of 1-1.5 cm.
The prescription point will be designated at the intersection of the multiple beams.
There are no planned interruptions > 3 days.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Time Frame
Weekly and 4 weeks after last dose of radiation
Secondary Outcome Measure Information:
Title
Dose-limiting toxicity
Time Frame
Weekly and 4 weeks after last dose of radiation
Title
Toxicity
Time Frame
Weekly and 4 weeks after last dose of radiation
Title
Tumor response rate
Time Frame
4 weeks after last dose of radiation and every 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nipun B. Merchant
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
12. IPD Sharing Statement
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PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca
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