Completed

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

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What is being tested

cetuximab

+ gemcitabine hydrochloride

BiologicalDrug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer 
NCT00075686
Principal SponsorSWOG Cancer Research Network
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

766 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

DISEASE CHARACTERISTICS: * Histologically\* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria: * Locally advanced unresectable disease * Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the histology must be compatible with pancreatic cancer * Measurable or nonmeasurable disease by x-ray, scan, or physical examination * Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry * None of the following tumor types are allowed: * Endocrine tumors * Lymphoma of the pancreas * Ampullary cancer * No known brain metastases PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2.0 times upper limit of normal (ULN) * SGOT or SGPT no greater than 2.5 times ULN Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No significant history of cardiac disease * No uncontrolled hypertension * No unstable angina * No uncontrolled arrhythmia * No congestive heart failure Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in remission PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for advanced pancreatic cancer * No prior cetuximab or other therapy that targets the epidermal growth factor pathway * No prior chimerized or murine monoclonal antibody therapy * No other concurrent anticancer immunotherapy Chemotherapy * At least 6 months since prior adjuvant chemotherapy * No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer * No prior gemcitabine * No other concurrent anticancer chemotherapy Endocrine therapy * No prior hormonal therapy for advanced pancreatic cancer * No concurrent anticancer hormonal therapy Radiotherapy * See Chemotherapy * At least 28 days since prior radiotherapy and recovered * Prior palliative radiotherapy to metastatic sites allowed * No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis) Surgery * At least 14 days since prior pancreatic cancer surgery and recovered Other * No other concurrent anticancer therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
gemcitabine hydrochloride 1000mg/m2, IV on Days 1,8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 389 locations

Suspended

Mobile Infirmary Medical Center

Mobile, United StatesSee the location
Suspended

East Alabama Medical Center

Opelika, United States
Suspended

Alaska Regional Hospital Cancer Center

Anchorage, United States
Suspended

Cancer Center at Providence Alaska Medical Center

Anchorage, United States
Completed389 Study Centers