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
- Conditions
- localized or loco-regional esophageal cancerMedDRA version: 9.1Level: LLTClassification code 10015362Term: Esophageal cancer
- Registration Number
- EUCTR2007-005051-42-CZ
- Lead Sponsor
- Protherics Salt Lake City, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 156
1) Disease criteria: Subject’s esophageal cancer must meet all of the following:
a) Confirmation: Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. Biopsy or cytology of the primary tumor or of involved regional lymph nodes is acceptable.
b) Stage: Tumors must be TNM stage T2-T3, N any, M0 (no evidence of disseminated cancer except regional node involvement which may be designated as M1a”) as determined by endoscopic ultrasound.
c) Disease extent: Disease must be limited to the esophagus or the gastroesophageal junction, including:
i)Tumor does not extend more than 2 cm into the stomach
ii)Tumor does not extend into proximal one-third of the esophagus (Note: Bronchoscopy is required if tumor is <26 cm from the incisors or at or above the carina)
iii)No tracheal-esophageal fistulas present
iv) No apparent direct invasion by the tumor into the mucosa of the trachea or major bronchus as determined by bronchoscopy or other method.
v) No vascular invasion or involvement by the tumor
d) No evidence of metastatic disease: disease must be localized to the esophagus, including
i) no malignant cytology of the pleura, pericardium or peritoneum
ii) no radiographic evidence of distant organ involvement including lung, liver or bone (Note: any imaging study suspicious of liver metastases must be followed up with a negative biopsy prior to enrolling subject in the study)
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 CRT
6) Karnofsky Performance Status of =60 (refer to Section 13.2 for details)
7) Minimum life expectancy of 4 months as determined by the Investigator
8) Adequate hematologic function, defined as
a) Absolute neutrophil count (ANC) =1500/mm3
b) Platelet count =100,000/mm3
c) Hemoglobin =9 g/dL
9) Adequate hepatic function, defined as
a) Total bilirubin <1.5 X upper limit of normal (ULN)
b) AST and ALT <3 X ULN
c) Albumin =3.0 g/dL or albumin =2 g/dL if the lower level is considered by the investigator to be due to nutritional depletion
10) Adequate renal function, defined as
a) Serum creatinine <1.5 mg/dL and/or creatinine clearance =65 mL/min
11) =18 years old
12) If subject is female, she is non-pregnant, non-lactating and of
a) Non-childbearing potential (defined as surgically sterile or one year post-menopausal)
b) Childbearing potential using adequate birth control and having a negative pregnancy test performed at Screening and again within 5 days of Dosing Day 1; adequate birth control measures are defined as hormonal, chemical or barrier methods or abstinence. Other birth control methods must receive Sponsor approval prior to subject enrollment
13) Capable of understanding and agreeing to fulfill the requirements of the protocol
14) Sign the IRB/EC approved consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) History of anaphylaxis to planned CT contrast agent; subjects with history of minor, mild allergic reactions (eg hives, rash, pruritis) to planned CT contrast agent may be premedicated with prednisone or other medications per institutional standard of care
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. Note: hormonal therapies (eg tamoxifen, anastrozole) and topical agents (eg 5-FU, imiquimod) will be allowed; no washout period will be required for these agents.
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. In addition, subjects with history of low risk prostatic carcinoma (ie clinical stage 1 or 2a, Gleason score <6, and prostate-specific antigen (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, see Section 13.4), uncontrolled hypertension, myocardial infarction within 3 months, severe bronchial obstruction, uncontrolled seizure disorder, peripheral neuropathy greater than CTCAE grade 1, or any disease requiring anticoagulant therapy
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 aversely affect subject safety.
11) Known esophageal varices
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method