Status:
COMPLETED
S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well cetuximab wo...
Detailed Description
OBJECTIVES: * Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy. * Determin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of 1 of the following sites:
- Thoracic esophagus, located \> 20 cm\* from the incisors
- Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: \*Tumors located \< 26 cm from the incisors must be confirmed by bronchoscopy and negative cytology
- Disease confined to the esophagus and periesophageal soft tissue
- Metastatic disease
- Measurable disease by x-ray, scanning, or physical examination
- Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease
- One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at the time of initial diagnosis with localized disease
- No known brain metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Not specified
- Renal
- Creatinine ≤ 1.5 times upper limit of normal
- Other
- No prior allergic reaction to chimerized or murine monoclonal antibodies
- No evidence of human anti-mouse antibodies (HAMA)
- 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 in complete remission
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior cetuximab
- Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- Surgery
- At least 3 weeks since prior thoraco-abdominal surgery and recovered
- Other
- No other prior therapy that specifically targets the epidermal growth factor pathway
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00096031
Start Date
October 1 2004
End Date
January 1 2010
Last Update
September 26 2018
Active Locations (152)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
3
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Eden Medical Center
Castro Valley, California, United States, 94546