Clinical trial NCT00193128: Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
Official title: A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Esophagus Cancer
Keywords: Esophagus Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
name: Aventis Pharmaceuticals
First posted: 2005-09-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.

Detailed description: Upon determination of eligibility, patients will be receive:

Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy

If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.
* Must be surgical candidates
* No previous treatment for esophageal cancer
* Must have measurable or evaluable disease
* Able to perform activities of daily living with minimal to no assistance
* Adequate bone marrow, liver and kidney function
* Provide written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Tumor location in the proximal esophagus
* Metastatic disease or locally advanced cancer
* Moderate to severe peripheral neuropathy
* Serious pre-existing medical illnesses
* Significant heart disease
* Treated for an invasive cancer within the previous 5 years
* Women who are pregnant or breast-feeding
* Age \< 18 years

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
timeFrame: 18 months
Secondary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: 18 months
measure: Overall Survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Oncology
state: California
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Atlanta
country: United States
facility: Atlanta Cancer Care
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Marietta
country: United States
facility: Wellstar Cancer Research
state: Georgia
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R. Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. doi: 10.1200/JCO.2009.24.8773. Epub 2010 Mar 29.