Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer

NCT00573131 | Terminated Phase 2 Results DMC

• 1 other identifier: PR016-CLN-pro003
• Study Type: interventional
• Target: 137
• Locations: 4 countries
• Sites: 20

Brief Summary

OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel. The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and 5-FU) and radiation therapy before surgery.

Conditions

Esophageal Cancer; Adenocarcinoma of the Esophagus; Squamous Cell Carcinoma

Keywords

Esophageal cancer; Localized esophageal cancer; Operable esophageal cancer; Loco-regional esophageal cancer; Esophagectomy; Phase 2; Paclitaxel; Tumor; Local; Chemotherapy; radiation therapy; surgery; OncoGel; Squamous cell carcinoma of the esophagus

Outcome Measures

Primary Outcomes (1)

• Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT

  Per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and by Spiral CT assessment: Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Screening and Week 12

Study Arms (2)

Group 1

EXPERIMENTAL

OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.

Drug: OncoGel (Paclitaxel gel); Drug: cisplatin; Drug: 5-FU; Radiation: radiation therapy; Procedure: esophageal resection

Group 2

ACTIVE COMPARATOR

Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.

Drug: cisplatin; Drug: 5-FU; Radiation: radiation therapy; Procedure: esophageal resection

Interventions

OncoGel (Paclitaxel gel) DRUG

6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy

Group 1

cisplatin DRUG

75 mg/m2 IV (in the vein) once on Day 1 and Day 29

Group 1; Group 2

5-FU DRUG

1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29

Group 1; Group 2

radiation therapy RADIATION

50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks

Group 1; Group 2

esophageal resection PROCEDURE

Removal of esophagus after completion of chemotherapy and radiation therapy

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus. Stage T2-T3, N any, M0 (no evidence of disseminated cancer except regional involvement which may be designated as "M1a"). No evidence of metastatic disease
• Medically able to tolerate major abdominal and/or thoracic surgery
• Able to undergo EUS procedure and pass EUS probe through esophageal lumen
• Able to receive concurrent systemic chemotherapy (cisplatin and 5-FU) and RT
• Clinical management plan includes esophagectomy after completion of two courses of chemoradiation therapy
• Karnofsky Performance Status of ≥ 60
• Minimum life expectancy of 4 months
• Hematologic function
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Platelet count ≥ 100,000/mm3
• Hemoglobin ≥ 9 g/dL
• Hepatic function:
• Total bilirubin \< 1.5 X upper limit of normal (ULN)
• AST and ALT \< 3 X ULN
• Albumin ≥ 3.0 g/dL or ≥ 2.0 g/dL if the lower level is considered by the investigator to be due to nutritional depletion

You may not qualify if:

• History of anaphylaxis to planned CT contrast agent
• Prior esophageal stent insertion, laser, or photodynamic therapy
• Prior chest RT or major esophageal surgery
• Any prior receipt of cytotoxic chemotherapeutic agents
• Prior receipt of other cancer treatments (ie, Chelation therapy), vaccines, or biological response modifiers/growth factors (ie, GM-CSF, IL-2) within the past 4 weeks.
• Prior malignancy unless disease free for ≥ 3 years. Note: basal cell/squamous carcinoma of the skin, in situ cervical or breast carcinoma, or superficial transitional cell bladder carcinoma will be allowed. Subjects with a history of low risk prostatic carcinoma (ie, clinical stage 1 or 2a, Gleason score \< or = 6 and PSA \<10 ng/mL at diagnosis) will be allowed
• Significant currently active systemic diseases including uncontrolled diabetes, severe heart disease (New York Heart Association Class III or IV), uncontrolled hypertension, myocardial infarction within 3 months, severe bronchial obstruction, uncontrolled seizure disorder, or peripheral neuropathy greater than CTCAE grade 1
• Allergies to any of the active or inactive components of OncoGel (ie, allergies to degradable PLGA \[poly(lactide-co-glycolide) sutures\])
• Receipt of an investigational drug or device within 30 days prior to signing informed consent
• Any medical condition or other circumstance that, in the Investigator's opinion, would prevent completion of the study, interfere with analysis of the study results, or potentially adversely affect subject safety
• Known esophageal varices

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (20)

University of California San Diego

San Diego, California, 92093, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Digestive Health Specialists of Tyler, Texas

Tyler, Texas, 75701, United States

Location

University Hospital Brno

Brno, 62500, Czechia

Location

Hospital Jablonec nad Nisou

Jablonec nad Nisou, 466 60, Czechia

Location

University Hospital Olomouc

Olomouc, 775 20, Czechia

Location

University Hospital Motol

Prague, 150 06, Czechia

Location

Massaryk's Hospital in Usti nad Labem

Ústí nad Labem, 401 13, Czechia

Location

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, 560029, India

Location

Amrita Institute of Medical Sciences

Kochi, Kerala, 682026, India

Location

Bombay Hospital & Medical Research Centre

Mumbai, Maharashtra, 400020, India

Location

Deenanath Mangeshkar Hospital

Erandwane, Pune, 411004, India

Location

Meenakshi Mission Hospital and Research Centre

Madurai, Tamil Nadu, 625107, India

Location

Samodzielny Publiczny Szpital Kliniczny

Lublin, 20-081, Poland

Location

Samodzielnego Publicznego Szpitala Klinicznego

Szczecin, 70-111, Poland

Location

Related Publications (1)

• DeWitt JM, Murthy SK, Ardhanari R, DuVall GA, Wallner G, Litka P, Daugherty C, Fowers K. EUS-guided paclitaxel injection as an adjunctive therapy to systemic chemotherapy and concurrent external beam radiation before surgery for localized or locoregional esophageal cancer: a multicenter prospective randomized trial. Gastrointest Endosc. 2017 Jul;86(1):140-149. doi: 10.1016/j.gie.2016.11.017. Epub 2016 Nov 24.

  PMID: 27890801 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Carcinoma, Squamous Cell; Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Limitations and Caveats

Study prematurely terminated due to lack of efficacy in primary endpoint.

Results Point of Contact

• Title: Jessie Stockwell
• Organization: Boston Scientific Corporation

jessie.stockwell@bsci.com

1-612-618-1136

Study Officials

• Kirk D Fowers, PhD

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 22, 2022
• Results First Posted: May 16, 2014

Record last verified: 2022-06

Locations

PL (2); CZ (5); IN (5); US (8)