Clinical trial · Interventional
S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer
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
NCT00075686CI-TRIAL-00019821completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gemcitabine hydrochloride + IMC-C225
- description
- 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.
- interventionNames
- Biological: cetuximab
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- gemcitabine hydrochloride alone
- description
- gemcitabine hydrochloride 1000mg/m2, IV on Days 1,8,15,22 of cycle 1 and Days 1,8,15 of all subsequent cycles.
- interventionNames
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTPhilip PA, Benedetti J, Fenoglio-Preiser C, et al.: Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA4509, 2007.
- DERIVEDPhilip PA, Benedetti J, Corless CL, Wong R, O'Reilly EM, Flynn PJ, Rowland KM, Atkins JN, Mirtsching BC, Rivkin SE, Khorana AA, Goldman B, Fenoglio-Preiser CM, Abbruzzese JL, Blanke CD. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205. J Clin Oncol. 2010 Aug 1;28(22):3605-10. doi: 10.1200/JCO.2009.25.7550. Epub 2010 Jul 6. PMID 20606093