Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer (VEOX)
This study is currently recruiting participants.
Verified June 2011 by Weill Medical College of Cornell University
Sponsor:
Weill Medical College of Cornell University
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01386346
First received: May 10, 2011
Last updated: June 29, 2011
Last verified: June 2011
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Purpose
The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Malignant Neoplasm of Cardio-esophageal Junction of Stomach |
Drug: Azacitidine Drug: Oxaliplatin Drug: Epirubicin Drug: Capecitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer |
Resource links provided by NLM:
Drug Information available for:
Azacitidine
Epirubicin hydrochloride
Epirubicin
Oxaliplatin
Capecitabine
U.S. FDA Resources
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- Evaluation of dose limiting toxicity (DLT) [ Time Frame: First 63 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 16 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose Level -1 |
Drug: Azacitidine
50 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles.
Other Names:
Drug: Oxaliplatin
130 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Epirubicin
50 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Capecitabine
625 mg/m2 orally twice daily beginning on Day 3 and will be taken without interruption for each 21-day cycle.
|
| Experimental: Dose Level 1 |
Drug: Azacitidine
75 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles.
Other Names:
Drug: Oxaliplatin
130 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Epirubicin
50 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Capecitabine
625 mg/m2 orally twice daily beginning on Day 3 and will be taken without interruption for each 21-day cycle.
|
| Experimental: Dose Level 2 |
Drug: Azacitidine
75 mg/m2 subcutaneous injection on Day 1-5 of a 21 day cycle. Repeat for a total of 3 cycles.
Other Names:
Drug: Oxaliplatin
130 mg/m2 IV on Day 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Epirubicin
50 mg/m2 IV on Day 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Capecitabine
625 mg/m2 orally twice daily beginning on Day 5 and will be taken without interruption for each 21-day cycle.
|
Detailed Description:
Currently patients with resectable (can be removed by surgery) esophageal cancer will receive chemotherapy before surgery to try to shrink the tumor before it is removed. This study will evaluate whether giving azacitidine before each cycle of chemotherapy to increase the shrinkage of the tumor prior to surgery is safe.
Azacitidine is currently approved by the Food and Drug Administration (FDA) for treatment of myelodysplastic syndrome (MDS). Azacitidine is not approved by the FDA for use in this study and is therefore considered investigational. Because azacitidine has not been given before in combination with epirubicin, oxaliplatin and capecitabine, we will also evaluate the safety and tolerability of azacitidine and find out what dose of azacitidine is safe to give with this chemotherapy.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the intrathoracic esophagus or gastroesophageal junction (GEJ) and deemed resectable by the thoracic surgeon.
- No prior chemotherapy for esophageal or GEJ cancer.
- ECOG Performance status 0-2.
- Adequate bone marrow, kidney and liver function.
- Ability to understand and the willingness to sign a written informed consent document.
- Subjects of child-bearing potential must agree to use effective means of contraception (men and women).
- Prior malignancy is acceptable if the subject is considered to be cured. In most cases this will mean a 5-year disease-free period.
Exclusion Criteria:
- Patients with cervical esophageal cancer or esophageal cancer with squamous cell carcinoma morphology.
- Subjects receiving any other investigational agent or received prior chemotherapy for esophageal or GEJ cancer.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, epirubicin, oxaliplatin, capecitabine and mannitol.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
- Pregnant (positive pregnancy test) or lactating women.
- Patients with active infection, serious inter-current medical conditions.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386346
Contacts
| Contact: Bryan J Schneider, M.D. | 646-962-2066 | bjs2004@med.cornell.edu |
Locations
| United States, New York | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Gina Mileo, R.N. 212-746-5490 gjm2003@med.cornell.edu | |
| Sub-Investigator: Elizabeta Popa, M.D. | |
| Sub-Investigator: Allyson Ocean, M.D. | |
| Sub-Investigator: Ronald Scheff, M.D. | |
| Sub-Investigator: Nasser Altorki, M.D. | |
| Sub-Investigator: Jeffery Port, M.D. | |
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
| Principal Investigator: | Bryan J Schneider, M.D. | Weill Medical College of Cornell University |
More Information
No publications provided
| Responsible Party: | Bryan Schneider, M.D., Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT01386346 History of Changes |
| Other Study ID Numbers: | 1012011450, VZ-ESOPH-PI-273 |
| Study First Received: | May 10, 2011 |
| Last Updated: | June 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Weill Medical College of Cornell University:
|
gastroesophageal junction GEJ esophageal esophagus |
Additional relevant MeSH terms:
|
Neoplasms Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Stomach Diseases Azacitidine |
Capecitabine Oxaliplatin Epirubicin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013