localized or loco-regional esophageal cancer MedDRA version: 9.1 Level: LLT Classification code 10015362 Term: Esophageal cancer
Conditions
Interventions
Product Name: OncoGel
Pharmaceutical Form: Gel for injection
INN or Proposed INN: Paclitaxel
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
Protherics Salt Lake City, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 nodes such as supraclavicular and celiac) 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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 - Prior esophageal stent insertion, laser or photodynamic therapy - Prior chest RT or major esophageal surgery - Any prior receipt of cytotoxic chemotherapeutic agents - 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. - 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 - 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, or peripheral neuropathy greater than CTCAE grade 1 - Allergies to any of the active or inactive components of OncoGel (ie, allergies to degradable PLGA [poly(lactide-co-glycolide) sutures]) - Receipt of an investigational drug or device within 30 days prior to signing informed consent - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical study is to evaluate the efficacy of OncoGel based on overall tumor response at the primary tumor site.;Secondary Objective: The secondary objectives of this clinical study are to further evaluate the efficacy of OncoGel and to determine its safety in combination with chemoradiotherapy (CRT).;Primary end point(s): The primary efficacy endpoint will be overall tumor response at the primary tumor site based on measurement of primary tumor volume (excluding involved lymph nodes) by spiral CT. An independent panel will undertake a blinded review of the CT scans and will calculate tumor volume. The OR rate is defined as the proportion of subjects achieving a CR or PR. A CR is defined as disappearance of the target esophageal lesion based on the spiral CT scan at Week 12. A PR is defined, using modified RECIST criteria, as a =65% decrease in tumor volume from baseline to Week 12 using spiral CT. | — |
Countries
Belgium, Czech Republic
Outcome results
None listed