S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Juncti… (NCT00096031) | Clinical Trial Compass
CompletedPhase 2
S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
United States63 participantsStarted 2004-10
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival at 6 Months
Timeframe: every 3 weeks while on treatment, then every 3 months