Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
Completed · Phase 2
Conditions studied: Adenocarcinoma of Stomach, Adenocarcinoma of GE Junction, Adenocarcinoma of Esophagus
In brief
The purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.
Key facts
- Study ID
- NCT00165191
- Run by
- Dana-Farber Cancer Institute
- People needed
- 32
- Starts
- 1998-08-01
- Expected to finish
- 2006-01-01
- Last updated by the study team
- 2009-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction or esophagus
- No more than one prior chemotherapy regimen
- ECOG performance status of < or equal to 2
- Life expectancy > 12 weeks
- ANC > 1,500/mm3
- Hemoglobin > 9.0 gm/dl
- Platelets > 100,000/mm3
- SGOT < 3 x ULN
- Total bilirubin < 2.0 mg/dl
- Creatinine < 1.5 mg/dl
You may not qualify if…
- Prior cisplatin or doxorubicin as neoadjuvant or adjuvant therapy with in 1 year of study entry
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Myocardial infarction in the past 6 months
- Major surgery in the past 2 weeks
- Uncontrolled serious medical or psychiatric illness
- Pregnant or lactating women
- Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- History or clinical evidence of congestive heart failure
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.