Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
This study has been terminated.
(The principle investigator decided not to continue with the trial)
Sponsor:
University of Colorado, Denver
Collaborators:
Bristol-Myers Squibb
Sanofi
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00430027
First received: January 30, 2007
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection [and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab] is feasible and tolerable.
| Condition | Intervention |
|---|---|
|
Esophageal Adenocarcinoma |
Drug: Capecitabine Drug: Oxaliplatin Drug: Cetuximab |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Overall toxicity [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.
| Enrollment: | 8 |
| Study Start Date: | November 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Capecitabine, oxaliplatin, cetuximab, and radiation therapy
Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
|
Drug: Capecitabine
Given 650 mg/m^2 BID on days of ration therapy, 825 mg/m^2 day 1-14, day 15-20 off x 4
Other Name: Xeloda
Drug: Oxaliplatin
Oxaliplatin 30 mg/m^2, 130mg/m2 IV Q 21 days x 4
Other Name: Eloxatin
Drug: Cetuximab
Initial Cetuximab 400 mg/m^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection
Other Name: Erbitux
|
Detailed Description:
It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- signed informed consent
- patients 18 years of age or older
- biopsy proven, non-recurrent primary adenocarcinoma of the thoracic esophagus or gastro-esophageal junction, disease confined to esophagus and peri-esophageal soft tissue, tumors at the gastroesophageal junction must be limited to no greater than 2 cm into the gastric cardia
- clinical stage T3, NO-1 or T1-2, N1 and MO or M1a (celiac axis lymph nodes are allowed)
- Karnofsky Performance Status of >60%
- forced expiratory volume at one second (FeV1) must be >1.0 L
- adequate bone marrow reserve equal to or absolute neutrophil count (ANC) > 1500/mcl, total white blood cell count (WBC) > 3000/mcl, platelets >100,000/mcl and hemoglobin > 10.0 g/dl (transfusion permitted)
- adequate hepatic function of direct serum bilirubin < 2 times the upper limit of normal, total bilirubin < 1.5 times the upper limit normal, alanine transaminase (ALT), aspartate transaminase (AST) < 2.5 times the upper limit normal, Alkaline phosphatase < 2.5 times the upper limit normal
- creatinine clearance > 50 ml/min
- female patients of childbearing potential must have a negative serum or urin pregnancy test within 7 days prior to starting therapy
Exclusion Criteria:
- no previous resection or attempted resection of an esophageal cancer
- women who are pregnant or lactating
- life expectancy < 3 months
- serious, uncontrolled concurrent infection(s)
- prior fluoropyrimidine therapy
- prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known Dihydro Pyrimidine Dehydrogenase Deficiency (DPD) deficiency
- treatment for other carcinomas within 5 years, except cured non-melanoma skin and treated in-situ cervical cancer
- history of or evidence of uncontrolled diabetes
- surgical procedure within 6 months of study entry
- participation in any investigational drug study within 4 weeks preceding the start of study treatment
- prior therapy with andy agent that specifically targets the Epidermal Growth Factor Receptor (EGFR) pathway
- prior severe infusion reaction to a monoclonal antibody
- acute hepatitis or known HIV
- clinically significant cardia disease
- evidence of metastases
- other serious uncontrolled medical conditions that the investigator feels might compromise study participation
- major surgery within 4 weeks of the start of treatment without complete recovery
- lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- known, existing uncontrolled coagulopathy
- unwillingness to give written informed consent
- unwillingness to participate or inability to comply with the protocol for the duration of the study
- neuropathy of grade 2 or greater
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430027
Locations
| United States, Colorado | |
| University of Colorado at Denver and Health Science Center | |
| Aurora, Colorado, United States, 80045 | |
Sponsors and Collaborators
University of Colorado, Denver
Bristol-Myers Squibb
Sanofi
Investigators
| Principal Investigator: | Tracey Schefter, MD | University of Colorado at Denver and Health Science Center |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00430027 History of Changes |
| Other Study ID Numbers: | 06-0011.cc |
| Study First Received: | January 30, 2007 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Colorado, Denver:
|
Esophageal Esophagus |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Esophageal Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Diseases Digestive System Diseases Oxaliplatin Capecitabine |
Cetuximab Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013