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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00573131
First received: December 11, 2007
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Adenocarcinoma of the Esophagus
Squamous Cell Carcinoma
Drug: OncoGel (Paclitaxel gel)
Drug: cisplatin
Drug: 5-FU
Radiation: radiation therapy
Procedure: esophageal resection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT [ Time Frame: Screening and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: December 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Drug: OncoGel (Paclitaxel gel)
6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy
Drug: cisplatin
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
Drug: 5-FU
1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29
Radiation: radiation therapy
50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
Procedure: esophageal resection
Removal of esophagus after completion of chemotherapy and radiation therapy
Active Comparator: Group 2
Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Drug: cisplatin
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
Drug: 5-FU
1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29
Radiation: radiation therapy
50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
Procedure: esophageal resection
Removal of esophagus after completion of chemotherapy and radiation therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 disease
  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 weeks.
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573131

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92093
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Digestive Health Specialists of Tyler, Texas
Tyler, Texas, United States, 75701
Czech Republic
University Hospital Brno
Brno, Czech Republic, 62500
Hospital Jablonec nad Nisou
Jablonec nad Nisou, Czech Republic, 466 60
University Hospital Olomouc
Olomouc, Czech Republic, 775 20
University Hospital Motol
Praha, Czech Republic, 150 06
Massaryk's Hospital in Usti nad Labem
Usti nad Labem, Czech Republic, 401 13
India
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India, 560029
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682026
Bombay Hospital & Medical Research Centre
Mumbai, Maharashtra, India, 400020
Deenanath Mangeshkar Hospital
Erandwane, Pune, India, 411004
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, India, 625107
Poland
Samodzielny Publiczny Szpital Kliniczny
Lublin, Poland, 20-081
Samodzielnego Publicznego Szpitala Klinicznego
Szczecin, Poland, 70-111
Sponsors and Collaborators
BTG International Inc.
Investigators
Study Director: Kirk D Fowers, PhD BTG International Inc.
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00573131     History of Changes
Other Study ID Numbers: PR016-CLN-pro003
Study First Received: December 11, 2007
Results First Received: April 17, 2014
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
India: Drugs Controller General of India
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by BTG International Inc.:
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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014