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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522795
• Other study ID #: BrUOG-E-215
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Est. completion date: April 2010

Study information

• Verified date: February 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• PPX with cisplatin and radiation
weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks

Locations

Country	Name	City	State
United States	Lifespan Hospitals	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	University of Maryland Greenebaum Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Pathologic Response	Per pathology review post surgery	At Surgery approximately 4weeks after last treatment