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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00573131
• Other study ID #: PR016-CLN-pro003
• Status: Terminated
• Phase: Phase 2
• Start date: January 2008
• Est. completion date: November 2010

Study information

• Verified date: June 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• OncoGel (Paclitaxel gel)
6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy
• cisplatin
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Czechia,  India,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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