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A Randomized Study of the Efficacy and Safety of OncoGel™ Treatment as an Adjunctive Therapy to Systemic Chemotherapy and Concurrent External Beam Radiation Prior to Surgery in Subjects With Localized or Loco-regional Esophageal Cancer

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer, Adenocarcinoma of the Esophagus, Squamous Cell Carcinoma

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Trial Information

A Randomized Study of the Efficacy and Safety of OncoGel™ Treatment as an Adjunctive Therapy to Systemic Chemotherapy and Concurrent External Beam Radiation Prior to Surgery in Subjects With Localized or Loco-regional Esophageal Cancer

The primary objective of this study is to evaluate the efficacy of OncoGel given in
combination with standard chemotherapy (cisplatin and 5-FU) and radiation therapy in
patients with previously untreated, resectable, local or local-regional adenosarcoma or
squamous cell carcinoma.

All patients will receive IV cisplatin on Day 1 and Day 29 and IV 5-FU given continuously
for 96 hours starting on Day 1 and Day 29. All patients will also receive out-patient
radiation therapy for 28 treatments once per day for 5 1/2 weeks starting on Day 1.

Patients randomized to the OncoGel treatment group will have the OncoGel dose injected into
their esophageal tumors during an endoscopic procedure just before starting systemic
chemotherapy and radiation therapy.

All patients will have CT scans for tumor measurements before starting chemotherapy and 12
weeks later after completion of the radiation therapy and both cycles of chemotherapy.

During the chemotherapy and radiation therapy, physical exams, vital signs, routine blood
tests will be performed. Patients will also be asked about their quality of life and ability
to swallow.

In-patient surgery will be scheduled 4 to 6 weeks after completion of chemotherapy and
radiation therapy. The resected esophagus and lymph nodes will be evaluated for the presence
of residual tumor.

Patients will be followed at months 4, 5, 6, and then every 3 Months thereafter for survival
and esophageal cancer status and treatment until the last patient enrolled has completed
their Month 12 visit.

Inclusion Criteria:

1. 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

2. Medically able to tolerate major abdominal and/or thoracic surgery

3. Able to undergo EUS procedure and pass EUS probe through esophageal lumen

4. Able to receive concurrent systemic chemotherapy (cisplatin and 5-FU) and RT

5. Clinical management plan includes esophagectomy after completion of two courses of
chemoradiation therapy

6. Karnofsky Performance Status of ≥ 60

7. Minimum life expectancy of 4 months

8. Hematologic function

- Absolute neutrophil count (ANC) ≥ 1500/mm3

- Platelet count ≥ 100,000/mm3

- Hemoglobin ≥ 9 g/dL

9. 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

10. Serum creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 65 mL/min

11. ≥ 18 years old

12. If female, must be non-pregnant, nonlactating, of non-childbearing potential, or
using adequate birth control

13. Capable of understanding and agreeing to fulfill the requirements of the protocol

14. Sign the IRB/EC approved consent form

Exclusion Criteria:

1. History of anaphylaxis to planned CT contrast agent

2. Prior esophageal stent insertion, laser, or photodynamic therapy

3. Prior chest RT or major esophageal surgery

4. Any prior receipt of cytotoxic chemotherapeutic agents

5. 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

6. 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

7. 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

8. Allergies to any of the active or inactive components of OncoGel (ie, allergies to
degradable PLGA [poly(lactide-co-glycolide) sutures])

9. Receipt of an investigational drug or device within 30 days prior to signing
informed consent

10. 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

11. Known esophageal varices

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall tumor response at the primary tumor site based on measurement of primary tumor volume (excluding involved lymph nodes) by spiral CT

Outcome Time Frame:

Screening and Week 12

Safety Issue:


Principal Investigator

Kirk D Fowers, PhD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Adenocarcinoma of the Esophagus
  • Squamous Cell Carcinoma
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms



Rush University Medical Center Chicago, Illinois  60612-3824
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Baylor University Medical Center Dallas, Texas  75246
University of California San Diego La Jolla, California  92093
University of Chicago Medical Center Chicago, Illinois  60637
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
Indiana University Medical Center Indianapolis, Indiana  46202
Digestive Health Specialists of Tyler, Texas Tyler, Texas  75701