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

Phase 2

Completed

• Conditions: Esophageal Cancer
• Interventions: Drug: PPX with cisplatin and radiation

• Registration Number: NCT00522795
• Lead Sponsor: Brown University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-29
• Study First Posted: 2007-08-30
• Primary Completion: 2010-02
• Study Completion: 2010-04
• Results First Submitted: 2013-05-21
• Results First Submitted QC: 2013-07-09
• Results First Posted: 2013-08-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPX with cisplatin and radiation	PPX with cisplatin and radiation	PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation

Primary Outcome Measures

Name	Time	Method
Complete Pathologic Response	At Surgery approximately 4weeks after last treatment	Per pathology review post surgery

Trial Locations

Locations (1)

Lifespan Hospitals; 🇺🇸 Providence, Rhode Island, United States