S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with cetuximab to see how well it works compared to giving gemcitabine alone as first-line therapy in treating patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas.
|Pancreatic Cancer||Biological: cetuximab Drug: gemcitabine hydrochloride||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer|
- Overall survival comparison between treatment groups [ Time Frame: every 4 weeks for 3 years ]
- Response rate comparison between treatment groups as measured by RECIST and radiological evaluation at every other course [ Time Frame: every 9 weeks until progression ]
- Time to treatment failure comparison between groups from registration to first observation of progressive disease, symptomatic deterioration, or death [ Time Frame: every 4 weeks while on treatment ]
- Percentage of patients with EGFR tumor expression and compare overall survival of patients in the EGFR subset [ Time Frame: every 4 weeks for 3 years ]
- Toxicity profile comparison of patients treated with 2 regimens and measured until 30 days after completion of study treatment [ Time Frame: every 4 weeks while on treatment ]
- Total response rate comparison between treatment groups in the subset of patients with measurable disease by RECIST at every other course [ Time Frame: every 9 weeks until progression ]
- Pain and quality of life comparison between treatment groups as measured by patient questionnaire at baseline, before each course, and then completion of study treatment [ Time Frame: every 4 weeks while on treatment ]
|Study Start Date:||January 2004|
|Study Completion Date:||April 2009|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: gemcitabine hydrochloride + IMC-C225
Loading dose: gemcitabine hydrochloride 1000mg/m2, IV on Day 1; Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only) Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 & days 1,8,15,22 of all subsequent cycles; gemcitabine hydrochloride 1000mg/m2, IV on Days 8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.
Loading dose: Cetuxiumab 400mg/m2, IV on Day 1 (cycle 1 only). Weekly maintenance: Cetuximab 250mg/m2, IV on Days 8,15,22 of cycle 1 & days 1,8,15,22 of all subsequent cyclesDrug: gemcitabine hydrochloride
1000mg/m2 IV over 30 minutes
Experimental: gemcitabine hydrochloride alone
gemcitabine hydrochloride 1000mg/m2, IV on Days 1,8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.
Drug: gemcitabine hydrochloride
1000mg/m2 IV over 30 minutes
- Compare the overall survival of patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas treated with gemcitabine and cetuximab vs gemcitabine alone.
- Compare the time to treatment failure in patients treated with these regimens.
- Estimate the percentage of patients with epidermal growth factor receptor (EGFR) tumor expression in patients treated with these regimens.
- Compare the overall survival of patients in the EGFR-positive subset treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the total response rate (confirmed and unconfirmed complete and partial response) in patients with measurable disease treated with these regimens.
- Compare the patient report of pain and quality of life of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to disease status (locally advanced unresectable vs metastatic), Zubrod performance status (0 or 1 vs 2), and prior pancreatectomy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22 and gemcitabine IV over 30 minutes on days 1, 8, 15, and 22 for course 1 and days 1, 8, and 15 for all subsequent courses.
- Arm II: Patients receive gemcitabine as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course, and at the end of study therapy.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 704 patients (352 per treatment arm) will be accrued for this study within 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075686
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|Study Chair:||Philip A. Philip, MD, PhD, FRCP||Barbara Ann Karmanos Cancer Institute|
|Study Chair:||Eileen O'Reilly, MD||Memorial Sloan Kettering Cancer Center|
|Study Chair:||Ralph PW Wong, MD, FRCPC||CancerCare Manitoba|