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

NCT ID: NCT00573131

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-11-30

Brief 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.

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.

Conditions

Esophageal Cancer; Adenocarcinoma of the Esophagus; Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.

Group Type: EXPERIMENTAL

OncoGel (Paclitaxel gel)

Intervention Type: DRUG

6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy

cisplatin

Intervention Type: DRUG

75 mg/m2 IV (in the vein) once on Day 1 and Day 29

5-FU

Intervention Type: DRUG

1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29

radiation therapy

Intervention Type: RADIATION

50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks

esophageal resection

Intervention Type: PROCEDURE

Removal of esophagus after completion of chemotherapy and radiation therapy

Group 2

Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.

Group Type: ACTIVE_COMPARATOR

cisplatin

Intervention Type: DRUG

75 mg/m2 IV (in the vein) once on Day 1 and Day 29

5-FU

Intervention Type: DRUG

1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29

radiation therapy

Intervention Type: RADIATION

50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks

esophageal resection

Intervention Type: PROCEDURE

Removal of esophagus after completion of chemotherapy and radiation therapy

Interventions

OncoGel (Paclitaxel gel)

6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy

Intervention Type: DRUG

cisplatin

75 mg/m2 IV (in the vein) once on Day 1 and Day 29

Intervention Type: 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

Intervention Type: DRUG

radiation therapy

50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks

Intervention Type: RADIATION

esophageal resection

Removal of esophagus after completion of chemotherapy and radiation therapy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirk D Fowers, PhD

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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

Countries

United States; Czechia; India; Poland

References

DeWitt JM, Murthy SK, Ardhanari R, DuVall GA, Wallner G, Litka P, Daugherty C, Fowers K. EUS-guided paclitaxel injection as an adjunctive therapy to systemic chemotherapy and concurrent external beam radiation before surgery for localized or locoregional esophageal cancer: a multicenter prospective randomized trial. Gastrointest Endosc. 2017 Jul;86(1):140-149. doi: 10.1016/j.gie.2016.11.017. Epub 2016 Nov 24.

Reference Type: DERIVED

PMID: 27890801 (View on PubMed)

Other Identifiers

PR016-CLN-pro003

Identifier Type: -

Identifier Source: org_study_id