Status:
COMPLETED
Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Adenocarcinoma of Stomach
Adenocarcinoma of GE Junction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
* Patients will receive cisplatin and doxorubicin intravenously once every 3 weeks. In addition to cisplatin and doxorubicin, patients will receive 5-fluorouracil intravenously as a continuous infusio...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00165191
Start Date
August 1 1998
End Date
January 1 2006
Last Update
April 28 2009
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115