Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

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

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

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

OncoGel (Paclitaxel gel)

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

cisplatin

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

5-FU

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

radiation therapy

Removal of esophagus after completion of chemotherapy and radiation therapy

esophageal resection

Kirk D Fowers, PhD

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.

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.

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

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

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

Boston Scientific Corporation

Serious adverse events were collected through the first 30 days after the Week 12 visit

Group 1

Group 2

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Czech Republic

Poland

Belgium

India

Region of Enrollment

Study prematurely terminated due to lack of efficacy in primary endpoint.

Jessie Stockwell

Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy.

Spots Global Cancer Trial Database for oncogel (paclitaxel gel)