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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Oxaliplatin

Docetaxel

Capecitabine

Radiation therapy

About this trial

This is an interventional treatment trial for Esophagus Cancer focused on measuring Esophagus Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tower Oncology
Integrated Community Oncology Network
Atlanta Cancer Care
Northeast Georgia Medical Center
Wellstar Cancer Research
Consultants in Blood Disorders and Cancer
Tennessee Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Overall Survival (OS)

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

Full Information

NCT ID

NCT00193128

First Posted

September 12, 2005

Last Updated

October 29, 2021

Sponsor

SCRI Development Innovations, LLC

Collaborators

Sanofi-Synthelabo, Aventis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00193128

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

Sanofi-Synthelabo, Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophagus Cancer

Keywords

Esophagus Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Other Intervention Name(s)

RT

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Disease-Free Survival (DFS)

Description

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

Time Frame

18 months

Title

Overall Survival (OS)

Description

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

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David R. Spigel, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tower Oncology

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Integrated Community Oncology Network

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Atlanta Cancer Care

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Northeast Georgia Medical Center

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Wellstar Cancer Research

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Consultants in Blood Disorders and Cancer

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Tennessee Oncology

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20351330

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.

Results Reference

result

Esophagus Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial