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

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer; Cancer of the Esophagus; Esophagus Cancer; Esophageal Neoplasm; Cancer of Esophagus

Intervention: Irinotecan (drug) (Drug); Taxotere (drug) (Drug); Radiotherapy (procedure) (Procedure); Esophagectomy (procedure) (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
James A. Posey, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham

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.

Clinical Details

Official title: A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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.

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.

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Additional Information

Starting date: January 2002
Last updated: December 30, 2010

Page last updated: August 23, 2015

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