Clinical trial · Interventional
S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
NCT00096031CI-TRIAL-00035036completedPhase 2Results postedClinicalTrials.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: 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.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- description
- 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
- interventionNames
- Biological: cetuximab
Primary outcomes (1)
- measure
- Overall Survival at 6 Months
- timeFrame
- every 3 weeks while on treatment, then every 3 months
- description
- Time to death is measured from date of registration to date of death due to any cause.
Secondary outcomes (2)
- measure
- Time to Treatment Failure
- timeFrame
- every 3 weeks while on treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.