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A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Esophagus Cancer

Thank you

Trial Information

A Phase I/II Trial of Preoperative Oxaliplatin, Docetaxel, and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery

Outcome Description:

The absence of any residual tumor cells in a histologic evaluation of a tumor specimen is defined as a complete pathologic response

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI GI 57

NCT ID:

NCT00193128

Start Date:

April 2004

Completion Date:

January 2009

Related Keywords:

  • Esophagus Cancer
  • Esophagus Cancer
  • Esophageal Neoplasms

Name

Location
Northeast Georgia Medical Center Gainesville, Georgia  30501
Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Atlanta Cancer Care Atlanta, Georgia  30342
Tennessee Oncology Nashville, Tennessee  37203
Tower Oncology Beverly Hills, California  90211
Wellstar Cancer Research Marietta, Georgia  30060