Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

Esophagus Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193128
• Other study ID #: SCRI GI 57
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2004
• Est. completion date: January 2009

Study information

• Verified date: October 2021
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Drug:
• Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
• Docetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
• Capecitabine
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.

Radiation:
• Radiation therapy
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).

Locations

Country	Name	City	State
United States	Atlanta Cancer Care	Atlanta	Georgia
United States	Tower Oncology	Beverly Hills	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Wellstar Cancer Research	Marietta	Georgia
United States	Tennessee Oncology	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 gast — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery	The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response	18 months
Secondary	Disease-Free Survival (DFS)	Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.	18 months
Secondary	Overall Survival (OS)	Length of time, in months, that patients were alive from their first date of protocol treatment until death.	36 months

External Links

•   Published article in the Journal of Clinical Oncology