Phase 2
N=63
S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00096031 ↗Enrolled (actual)
63
Serious AEs
1.8%
Results posted
May 2012
Primary outcome: Primary: Overall Survival at 6 Months — 36 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cetuximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 6 Months |
36 | — |
| SECONDARY Time to Treatment Failure |
1.8 | — |
| SECONDARY Time to Progression |
1.8 | — |
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 works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00096031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.