Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
1 other identifier
interventional
32
1 country
2
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 adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 1998
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1998
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedApril 28, 2009
April 1, 2009
7.4 years
September 9, 2005
April 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the activity of doxorubicin, cisplatin and continuous infusion of 5-fluorouracil in patients with measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction, or esophagus.
Secondary Outcomes (2)
Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population
evaluate the survival of this patient population.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Kulke, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
August 1, 1998
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
April 28, 2009
Record last verified: 2009-04