Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer
A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer
2 other identifiers
interventional
25
1 country
1
Brief Summary
There is a need for more effective therapy for patients following surgery for esophageal carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in this disease. There is interest in the combination of these two active agents plus radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2002
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 13, 2006
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedMay 25, 2023
May 1, 2023
April 13, 2006
May 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The determination of pathologic response in patients who undergo surgical resection.
Approximately 14 weeks before eligible patients have surgery
Secondary Outcomes (2)
To assess the overall survival, time to treatment failure, and quality of life in patients who receive any therapy
Approximately 4 months
To assess the toxicities associated with this treatment and any impact on surgery.
Approximately 4 months
Study Arms (1)
Taxotere/Irinotecan
EXPERIMENTALTaxotere and Irinotecan is given intravenously for 3 consecutive weeks with a one-week break before radiotherapy for 5-6 weeks. A combination of Taxotere and Irinotecan will then be administered simultaneously with the radiotherapy.
Interventions
50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
Radiotherapy will be given in 28 fractions over 5-6 weeks at 1.8 Gy per fraction for a total of 50.4 Gy. This will begin concurrently with chemotherapy on Day 29 of treatment.
After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.
Eligibility Criteria
You may qualify if:
- Histological confirmation of adenocarcinoma/squamous cell carcinoma of the esophagus. Patients should be considered resection candidates, Clinical Stages II- IV (For GE junction tumors 50% of the tumor must be within the esophagus)
- Age 19 years
- Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required, and women with reproductive potential shall have a negative pregnancy test.
- Patient should be able to understand and offer signed written informed consent prior to study entry.
- No prior receipt of surgery, chemotherapy, radiotherapy or immunotherapy.
- Patients must demonstrate a ECOG P.S. ≤ 1
- Minimum life expectancy of 12 weeks
- End Organ function must be adequate meeting the below criteria at baseline:
- WBC 3000/mm3, ANC 1500/mm3 , Hgb 9.0 g/dL, PLT 100,000mm3 Normal serum creatinine ( 1.5 mg/dL) Total Bilirubin ULN, Transaminases (SGOT and/or SGPT) may be up to 1.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is \< ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are \< ULN.
- PT/PTT below the upper limit of normal (patients may be on 1mg of Coumadin for line patency) Peripheral neuropathy must be \< Grade 1
You may not qualify if:
- Diagnosis of active, invasive (treated in past 5 years) concomitant malignancy except non-melanotic skin cancer
- Patients must be fully recovered from any reversible side effects of prior intervention
- Presence of an underlying disease state associated with impairment of performance status
- New York Heart Association Class IV congestive heart failure
- Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided
- History of non-compliance with prescribed medical care.
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Aventis Pharmaceuticalscollaborator
- Pharmacia and Upjohncollaborator
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James A. Posey, M.D.
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Proffessor
Study Record Dates
First Submitted
April 13, 2006
First Posted
April 27, 2006
Study Start
January 1, 2002
Study Completion
April 1, 2006
Last Updated
May 25, 2023
Record last verified: 2023-05