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Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer

Primary Purpose

Esophageal Cancer, Cancer of the Esophagus, Esophagus Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Irinotecan (drug)
Taxotere (drug)
Radiotherapy (procedure)
Esophagectomy (procedure)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Chemotherapy for cancer of the esophagus, Radiotherapy for cancer of the esophagus, Surgery for cancer of the esophagus, Chemotherapy, radiotherapy, surgery for esophageal cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Taxotere/Irinotecan

Arm Description

Taxotere 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.

Outcomes

Primary Outcome Measures

The determination of pathologic response in patients who undergo surgical resection.

Secondary Outcome Measures

To assess the overall survival, time to treatment failure, and quality of life in patients who receive any therapy
To assess the toxicities associated with this treatment and any impact on surgery.

Full Information

First Posted
April 13, 2006
Last Updated
May 24, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Aventis Pharmaceuticals, Pharmacia and Upjohn
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1. Study Identification

Unique Protocol Identification Number
NCT00318903
Brief Title
Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer
Official Title
A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Aventis Pharmaceuticals, Pharmacia and Upjohn

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The high rate of local and distant failure following surgery for esophageal carcinoma necessitates a more effective therapy for these patients. The merit of neoadjuvant chemotherapy is early management of micrometastatic disease and radiosensitization. A longstanding regimen, 5-FU and Cisplatin, have failed to produce a substantial survival benefit, but the approach has resulted in pathologic complete responses prior to surgical eradication of the diseased organ. This raises questions of organ preservation in some patients. Docetaxel and Irinotecan have both demonstrated independent activity in this disease and are radiosensitizers. In this study, Docetaxel and Irinotecan will be given together weekly for 3 consecutive weeks in an attempt to decrease the recurrence of systemic disease, and this will be followed by giving each agent independently with radiation therapy to decrease the local relapse rate and independently measure the toxicity of each with radiation. Following completion of chemoradiotherapy, the patients will undergo resection and be evaluated for the pathologic response rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Cancer of the Esophagus, Esophagus Cancer, Esophageal Neoplasm, Cancer of Esophagus
Keywords
Chemotherapy for cancer of the esophagus, Radiotherapy for cancer of the esophagus, Surgery for cancer of the esophagus, Chemotherapy, radiotherapy, surgery for esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taxotere/Irinotecan
Arm Type
Experimental
Arm Description
Taxotere 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.
Intervention Type
Drug
Intervention Name(s)
Irinotecan (drug)
Other Intervention Name(s)
Camptosar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Taxotere (drug)
Other Intervention Name(s)
Docetaxel
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy (procedure)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy (procedure)
Intervention Description
After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.
Primary Outcome Measure Information:
Title
The determination of pathologic response in patients who undergo surgical resection.
Time Frame
Approximately 14 weeks before eligible patients have surgery
Secondary Outcome Measure Information:
Title
To assess the overall survival, time to treatment failure, and quality of life in patients who receive any therapy
Time Frame
Approximately 4 months
Title
To assess the toxicities associated with this treatment and any impact on surgery.
Time Frame
Approximately 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A. Posey, M.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer

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