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

NCT00522795 | Completed Phase 2 Results DMC

• 1 other identifier: BrUOG-E-215
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Complete Pathologic Response

  Per pathology review post surgery

  At Surgery approximately 4weeks after last treatment

Study Arms (1)

PPX with cisplatin and radiation

EXPERIMENTAL

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

Drug: PPX with cisplatin and radiation

Interventions

PPX with cisplatin and radiation DRUG

weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks

Also known as: Paclitaxel Poliglumex, Cisplatin and radiation

PPX with cisplatin and radiation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brown University: lead
• University of Maryland Greenebaum Cancer Center: collaborator

Study Sites (1)

Lifespan Hospitals

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

protein phosphatase 4; Cisplatin; Radiation; paclitaxel poliglumex

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Results Point of Contact

• Title: Kayla Rosati
• Organization: BrUOG

Kayla_Rosati@brown.edu

401-863-3000

Study Officials

• Howard Safran, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 30, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 17, 2020
• Results First Posted: August 22, 2013

Record last verified: 2020-02

Locations

US (1)