Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)

Study Overview
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Brief Summary
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Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

Detailed Description
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32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.

Official Title
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BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: PPX with cisplatin and radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction Patients may have celiac adenopathy There must be no evidence of distant organ metastases No prior chemotherapy or radiation for esophageal cancer Patients must be > 18 years of age, and non pregnant Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2.0 and bilirubin < 1.5 x ULN-ECOG performance status 0-1. Female patients, must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible No contraindications to esophagectomy Signed informed consent Exclusion Criteria: Active or uncontrolled infection Patients must not have other coexistent medical condition that would preclude protocol therapy. Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPX with cisplatin and radiation<br>PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation | Drug: PPX with cisplatin and radiation<br>* weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks<br>* Other names: Paclitaxel Poliglumex, Cisplatin and radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Pathologic Response | Per pathology review post surgery | At Surgery approximately 4weeks after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer