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

This study has been completed.
Sponsor:
Collaborators:
Sanofi-Synthelabo
Aventis Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193128
First received: September 12, 2005
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Esophagus Cancer
Drug: Oxaliplatin
Drug: Docetaxel
Drug: Capecitabine
Radiation: Radiation therapy
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The absence of any residual tumor cells in a histologic evaluation of a tumor specimen is defined as a complete pathologic response


Secondary Outcome Measures:
  • Disease-Free Survival (DFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.

  • Overall Survival (OS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Length of time, in months, that patients were alive from their first date of protocol treatment until death.


Enrollment: 59
Study Start Date: April 2004
Study Completion Date: January 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1

An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. 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).

Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.

Drug: Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Other Name: Eloxatin
Drug: Docetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Other Name: Taxotere
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).
Other Name: RT
Experimental: Cohort 2

After completion of the first phase of the trial, the second cohort began treatment.

Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. 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).

Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.

Drug: Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Other Name: Eloxatin
Drug: Docetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Other Name: Taxotere
Drug: 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.
Other Name: Xeloda
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).
Other Name: RT

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193128

Locations
United States, California
Tower Oncology
Beverly Hills, California, United States, 90211
United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
United States, Georgia
Atlanta Cancer Care
Atlanta, Georgia, United States, 30342
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Sanofi-Synthelabo
Aventis Pharmaceuticals
Investigators
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193128     History of Changes
Other Study ID Numbers: SCRI GI 57
Study First Received: September 12, 2005
Results First Received: March 26, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Esophagus Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Capecitabine
Docetaxel
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014