Status:
TERMINATED
S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or c...
Detailed Description
OBJECTIVES: Primary * Determine the 2-year overall survival of patients with previously untreated, clinically unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the esophagu...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors\*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)
- Disease confined to the esophagus or peri-esophageal soft tissue
- T4, M0 disease
- Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease
- NOTE: \*Patients with primary disease \< 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks
- Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
- Tumor specimens available
- No recurrent disease
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
- White Blood Cell (WBC) count ≥ 3,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10.0 g/dL
- Hepatic
- Albumin normal
- Bilirubin normal
- Alkaline phosphatase normal
- Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal
- Renal
- Creatinine clearance \> 50 mL/min
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior severe reaction to monoclonal antibodies
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for esophageal cancer
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy for esophageal cancer
- No concurrent intensity modulated radiotherapy
- No concurrent cobalt-60
- Surgery
- No prior surgical resection or attempted surgical resection of esophageal cancer
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00109850
Start Date
May 1 2005
End Date
May 1 2012
Last Update
November 18 2015
Active Locations (132)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
4
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505