S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Biological: cetuximab
- Registration Number
- NCT00075686
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 766
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description gemcitabine hydrochloride + IMC-C225 gemcitabine hydrochloride 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. gemcitabine hydrochloride alone gemcitabine hydrochloride gemcitabine hydrochloride 1000mg/m2, IV on Days 1,8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles. gemcitabine hydrochloride + IMC-C225 cetuximab 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.
- Primary Outcome Measures
Name Time Method Overall survival comparison between treatment groups every 4 weeks for 3 years
- Secondary Outcome Measures
Name Time Method Toxicity profile comparison of patients treated with 2 regimens and measured until 30 days after completion of study treatment 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 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 every 4 weeks while on treatment Response rate comparison between treatment groups as measured by RECIST and radiological evaluation at every other course every 9 weeks until progression Time to treatment failure comparison between groups from registration to first observation of progressive disease, symptomatic deterioration, or death every 4 weeks while on treatment Percentage of patients with EGFR tumor expression and compare overall survival of patients in the EGFR subset every 4 weeks for 3 years
Trial Locations
- Locations (387)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
East Alabama Medical Center
🇺🇸Opelika, Alabama, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Cancer Center at Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Banner Thunderbird Medical Center
🇺🇸Glendale, Arizona, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Ft. Smith, Arkansas, United States
Highlands Oncology Group - Springdale
🇺🇸Springdale, Arkansas, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Scroll for more (377 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States