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

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BTG International Inc.
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

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