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

Stopped early · Phase 2

Conditions studied: Esophageal Cancer, Adenocarcinoma of the Esophagus, Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00573131

Run by

Boston Scientific Corporation

People needed

137

Starts

2008-01-01

Expected to finish

2010-11-01

Last updated by the study team

2022-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Serum creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 65 mL/min
• ≥ 18 years old
• If female, must be non-pregnant, nonlactating, of non-childbearing potential, or using adequate birth control
• Capable of understanding and agreeing to fulfill the requirements of the protocol
• Sign the IRB/EC approved consent form

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

Where it is running

• University of California San Diego — San Diego, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Digestive Health Specialists of Tyler, Texas — Tyler, Texas, United States
• University Hospital Brno — Brno, Czechia
• Hospital Jablonec nad Nisou — Jablonec nad Nisou, Czechia
• University Hospital Olomouc — Olomouc, Czechia
• University Hospital Motol — Prague, Czechia
• Massaryk's Hospital in Usti nad Labem — Ústí nad Labem, Czechia
• Kidwai Memorial Institute of Oncology — Bangalore, Karnataka, India
• Amrita Institute of Medical Sciences — Kochi, Kerala, India
• Bombay Hospital & Medical Research Centre — Mumbai, Maharashtra, India
• Deenanath Mangeshkar Hospital — Erandwane, Pune, India
• Meenakshi Mission Hospital and Research Centre — Madurai, Tamil Nadu, India
• Samodzielny Publiczny Szpital Kliniczny — Lublin, Poland
• Samodzielnego Publicznego Szpitala Klinicznego — Szczecin, Poland

Full record on ClinicalTrials.gov

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