PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca
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.
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer|
- Maximum Tolerated Dose [ Time Frame: Weekly and 4 weeks after last dose of radiation ] [ Designated as safety issue: Yes ]
- Dose-limiting toxicity [ Time Frame: Weekly and 4 weeks after last dose of radiation ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: Weekly and 4 weeks after last dose of radiation ] [ Designated as safety issue: Yes ]
- Tumor response rate [ Time Frame: 4 weeks after last dose of radiation and every 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
|Experimental: Therapeutic Intervention||
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.
Other Name: ErbituxDrug: gemcitabine hydrochloride
Dose Level Gemcitabine dose Gemcitabine infusion
-1 150mg/m2 15 Minutes 0 200mg/m2 20 minutes
Other Name: GemzarRadiation: radiation therapy
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467116
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Nipun B. Merchant||Vanderbilt-Ingram Cancer Center|