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Completed

NCT Number: NCT00193128

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

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.

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tower Oncology, Beverly Hills, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin

Drug

40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts

Other names: Eloxatin

docetaxel

Drug

20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts

Other names: Taxotere

Capecitabine

Drug

In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.

Other names: Xeloda

radiation therapy

Radiation

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).

Other names: RT

Primary outcomes

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

    Time frame: 18 months

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

Secondary outcomes

  1. Disease-Free Survival (DFS)

    Time frame: 18 months

    Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.

  2. Overall Survival (OS)

    Time frame: 36 months

    Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Aventis Pharmaceuticals
  • Sanofi-Synthelabo

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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