Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer
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ClinicalTrials.gov Identifier: NCT00573131 |
Recruitment Status
:
Terminated
(OncoGel did not show any impact on overall tumor response)
First Posted
: December 13, 2007
Results First Posted
: May 16, 2014
Last Update Posted
: February 9, 2016
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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 or disease | Intervention/treatment | 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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
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
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- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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Hematologic function
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
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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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573131
United States, California | |
University of California San Diego | |
San Diego, California, United States, 92093 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
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 |
Study Director: | Kirk D Fowers, PhD | BTG International Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | BTG International Inc. |
ClinicalTrials.gov Identifier: | NCT00573131 History of Changes |
Other Study ID Numbers: |
PR016-CLN-pro003 |
First Posted: | December 13, 2007 Key Record Dates |
Results First Posted: | May 16, 2014 |
Last Update Posted: | February 9, 2016 |
Last Verified: | January 2016 |
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:
Carcinoma, Squamous Cell Adenocarcinoma Esophageal Neoplasms Carcinoma 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 Paclitaxel Albumin-Bound Paclitaxel Cisplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |