Esophageal CancerPhase 2NCT00318903
Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer
A Phase 2 study testing Irinotecan (drug), Taxotere (drug) and Radiotherapy (procedure) in people with Esophageal Cancer and Cancer of the Esophagus, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Esophageal Cancer, Cancer of the Esophagus, Esophagus Cancer
- What is being tested?
- Irinotecan (drug), Taxotere (drug) and Radiotherapy (procedure)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer
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.
Read the 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.
- Conditions
- Esophageal Cancer, Cancer of the Esophagus, Esophagus Cancer, Esophageal Neoplasm, Cancer of Esophagus
- Being tested
- Irinotecan (drug), Taxotere (drug), Radiotherapy (procedure), Esophagectomy (procedure)
- 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
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan (drug)Drug
Also called Camptosar
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 (drug)Drug
Also called Docetaxel
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 (procedure)Procedure or surgery
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.
Esophagectomy (procedure)Procedure or surgery
After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.
| Study group | Role | What they receive |
|---|---|---|
| Taxotere/Irinotecan | Experimental | 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. Receives: Drug: Irinotecan (drug); Drug: Taxotere (drug); Procedure: Radiotherapy (procedure); Procedure: Esophagectomy (procedure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The determination of pathologic response in patients who undergo surgical resection.
Measured: 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
Measured: Approximately 4 months
To assess the toxicities associated with this treatment and any impact on surgery.
Measured: Approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startJan 2002
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Pharmacia and Upjohn
- Responsible party
- Principal investigator, Michael James Bertram, University of Alabama at Birmingham
- Investigators
- James A. Posey, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318903
- Sponsor's protocol ID
- F001130016
- Other IDs
- UAB 0032
- Status last verified
- May 2023
- First submitted
- 13 Apr 2006
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00318903
- Acronym / sponsor ID
- F001130016
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Pharmacia and Upjohn
- Study start
- Jan 2002
- Study completion
- Apr 2006 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taxotere/Irinotecan | Experimental | Drug: Irinotecan (drug), Drug: Taxotere (drug), Procedure: Radiotherapy (procedure), Procedure: Esophagectomy (procedure)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan (drug)Also: Camptosar50 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. | Drug | Taxotere/Irinotecan |
| Taxotere (drug)Also: DocetaxelTaxotere 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. | Drug | Taxotere/Irinotecan |
| Radiotherapy (procedure)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. | Procedure or surgery | Taxotere/Irinotecan |
| Esophagectomy (procedure)After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible. | Procedure or surgery | Taxotere/Irinotecan |
Primary outcome
The determination of pathologic response in patients who undergo surgical resection.
Time frame: Approximately 14 weeks before eligible patients have surgery
2 secondary outcomes
To assess the overall survival, time to treatment failure, and quality of life in patients who receive any therapy
Time frame: Approximately 4 months
To assess the toxicities associated with this treatment and any impact on surgery.
Time frame: Approximately 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A. Posey, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan (drug), Taxotere (drug) and Radiotherapy (procedure) in people with Esophageal Cancer and Cancer of the Esophagus, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The determination of pathologic response in patients who undergo surgical resection. (time frame: Approximately 14 weeks before eligible patients have surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.