Status:
COMPLETED
S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
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. * C...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT00075686
Start Date
January 1 2004
End Date
April 1 2009
Last Update
November 17 2015
Active Locations (389)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
East Alabama Medical Center
Opelika, Alabama, United States, 36801-5452
3
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
4
Cancer Center at Providence Alaska Medical Center
Anchorage, Alaska, United States, 99519-6604