Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Protherics.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Protherics
Information provided by:
Protherics
ClinicalTrials.gov Identifier:
NCT00573131
First received: December 11, 2007
Last updated: August 14, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Adenocarcinoma of the Esophagus Squamous Cell Carcinoma |
Drug: OncoGel (Paclitaxel gel) Drug: cisplatin Drug: 5-FU Radiation: radiation therapy Procedure: esophageal resection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Protherics:
Primary Outcome Measures:
- Overall tumor response at the primary tumor site based on measurement of primary tumor volume (excluding involved lymph nodes) by spiral CT [ Time Frame: Screening and Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall tumor response at the primary tumor site based on measurement of the longest diameter and largest cross-sectional area of the primary tumor (excluding involved lymph nodes) by spiral CT [ Time Frame: Screening and Week 12 ] [ Designated as safety issue: No ]
- Presence and viability of cancer in resection samples (eg, Pathologic complete response (pCR), Pathologic microscopic residual disease (pCRmicro), R0, R1, R2 resections [ Time Frame: After Week 12 and surgical resection ] [ Designated as safety issue: No ]
- Absence of metastatic disease at Week 12 (prior to surgery) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Ability to undergo surgical resection [ Time Frame: After Week 12 ] [ Designated as safety issue: No ]
- Adverse events including radiation and chemotherapy-related toxicities, and changes in clinical laboratory measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Patient survival [ Time Frame: at least 1 year ] [ Designated as safety issue: No ]
- Change from baseline in dysphagia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Karnofsky and/or ECOG performance status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 124 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
|
Drug: OncoGel (Paclitaxel gel)
6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy
Drug: cisplatin
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
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
Radiation: radiation therapy
50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
Procedure: esophageal resection
Removal of esophagus after completion of chemotherapy and radiation therapy
|
|
Active Comparator: Group 2
Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
|
Drug: cisplatin
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
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
Radiation: radiation therapy
50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
Procedure: esophageal resection
Removal of esophagus after completion of chemotherapy and radiation therapy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Medically able to tolerate major abdominal and/or thoracic surgery
- Able to undergo EUS procedure and pass EUS probe through esophageal lumen
- Able to receive concurrent systemic chemotherapy (cisplatin and 5-FU) and RT
- Clinical management plan includes esophagectomy after completion of two courses of chemoradiation therapy
- Karnofsky Performance Status of ≥ 60
- Minimum life expectancy of 4 months
Hematologic function
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
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
- Serum creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 65 mL/min
- ≥ 18 years old
- If female, must be non-pregnant, nonlactating, of non-childbearing potential, or using adequate birth control
- Capable of understanding and agreeing to fulfill the requirements of the protocol
- Sign the IRB/EC approved consent form
Exclusion Criteria:
- History of anaphylaxis to planned CT contrast agent
- 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.
- 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
- 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
- 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 adversely affect subject safety
- Known esophageal varices
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573131
Locations
| United States, California | |
| University of California San Diego | |
| San Diego, California, United States, 92093 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Digestive Health Specialists of Tyler, Texas | |
| Tyler, Texas, United States, 75701 | |
| Czech Republic | |
| University Hospital Brno | |
| Brno, Czech Republic, 62500 | |
| Hospital Jablonec nad Nisou | |
| Jablonec nad Nisou, Czech Republic, 466 60 | |
| University Hospital Olomouc | |
| Olomouc, Czech Republic, 775 20 | |
| University Hospital Motol | |
| Praha, Czech Republic, 150 06 | |
| Massaryk's Hospital in Usti nad Labem | |
| Usti nad Labem, Czech Republic, 401 13 | |
| India | |
| Kidwai Memorial Institute of Oncology | |
| Bangalore, Karnataka, India, 560029 | |
| Amrita Institute of Medical Sciences | |
| Kochi, Kerala, India, 682026 | |
| Bombay Hospital & Medical Research Centre | |
| Mumbai, Maharashtra, India, 400020 | |
| Deenanath Mangeshkar Hospital | |
| Erandwane, Pune, India, 411004 | |
| Meenakshi Mission Hospital and Research Centre | |
| Madurai, Tamil Nadu, India, 625107 | |
| Poland | |
| Samodzielny Publiczny Szpital Kliniczny | |
| Lublin, Poland, 20-081 | |
| Samodzielnego Publicznego Szpitala Klinicznego | |
| Szczecin, Poland, 70-111 | |
Sponsors and Collaborators
Protherics
Investigators
| Study Director: | Kirk D Fowers, PhD | Protherics |
More Information
No publications provided
| Responsible Party: | Kirk D. Fowers, PhD, Protherics |
| ClinicalTrials.gov Identifier: | NCT00573131 History of Changes |
| Other Study ID Numbers: | PR016-CLN-pro003 |
| Study First Received: | December 11, 2007 |
| Last Updated: | August 14, 2010 |
| Health Authority: | United States: Food and Drug Administration Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Czech Republic: State Institute for Drug Control India: Drugs Controller General of India Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Keywords provided by Protherics:
|
Esophageal cancer Localized esophageal cancer Operable esophageal cancer Loco-regional esophageal cancer Esophagectomy Phase 2 Paclitaxel |
Tumor Local Chemotherapy radiation therapy surgery OncoGel Squamous cell carcinoma of the esophagus |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Head and Neck Neoplasms Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013