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Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

capecitabine

oxaliplatin

gene expression analysis

microarray analysis

reverse transcriptase-polymerase chain reaction

adjuvant therapy

biopsy

conventional surgery

neoadjuvant therapy

quality-of-life assessment

radiation therapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus
- Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound
- Bulk of gastroesophageal junction tumor should be in the esophagus
Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors
No known brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy > 4 months
WBC > 4,000/mm³
ANC > 1,500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 9 g/dL
Bilirubin normal
Creatinine normal
AST < 2.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3 times ULN
Able to take oral medication or undergo enteral administration of medication
No peripheral neuropathy ≥ grade 2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 90 days after completion of study treatment
No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy
No concurrent uncontrolled illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would preclude study compliance
No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- Other cured tumors allowed at discretion of the principal investigator
No known HIV or hepatitis B or C (active and/or previously treated)

PRIOR CONCURRENT THERAPY:

No prior therapy for esophageal cancer
No other concurrent investigational agents

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo

Arm Description

Oxaliplatin 85 mg/m2 will be administered IV on days 1, 15 and 29. Capecitabine 1250 mg/m2 will be administered in 2 divided daily doses P0 or via enteral tube, on radiation days only (Monday- Friday/ weekly). Capecitabine will be continued until the final dose of radiotherapy

Outcomes

Primary Outcome Measures

Complete Response

Secondary Outcome Measures

Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1

Median Time to Progression

Quality of Life Improved Rate

Full Information

NCT ID

NCT00470184

First Posted

May 3, 2007

Last Updated

September 19, 2013

Sponsor

Roswell Park Cancer Institute

Collaborators

National Comprehensive Cancer Network

1. Study Identification

Unique Protocol Identification Number

NCT00470184

Brief Title

Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

Official Title

Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

Collaborators

National Comprehensive Cancer Network

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer.

Detailed Description

OBJECTIVES: Primary Determine the complete pathologic response (complete response [CR]) rate in patients with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine, and radiotherapy. Secondary Determine the clinical efficacy and toxicity of this regimen in these patients. Determine the quality of life of patients treated with this regimen. Identify basal expression and changes in gene expression that relate to CR, relapse, and survival of patients treated with this regimen. OUTLINE: Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 (weeks 1, 3, and 5). Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 and receive oral or enteral capecitabine twice daily on the same days they undergo radiotherapy. Surgery: At 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients who are eligible undergo esophagectomy. Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and oral or enteral capecitabine twice daily on days 1-5, 8-12, 15-19, 22-26, and 29. Treatment repeats approximately every 14 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies periodically. Collected samples are analyzed by gene expression studies, microarray analysis, and real-time quantitative reverse transcriptase-PCR to identify basal expression and changes in gene expression. Quality of life is assessed periodically. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

6. Conditions and Keywords

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

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemo

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention Description

Intervention Type

Genetic

Intervention Name(s)

gene expression analysis

Intervention Description

Correlative Study

Intervention Type

Genetic

Intervention Name(s)

microarray analysis

Intervention Description

Correlative Study

Intervention Type

Genetic

Intervention Name(s)

reverse transcriptase-polymerase chain reaction

Intervention Description

Correlative Study

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Description

Metastatic growth control

Intervention Type

Procedure

Intervention Name(s)

biopsy

Intervention Description

Examination of tissue type

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Description

Tissue removal

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Intervention Description

Tumor shrinkage

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Description

Correlative Study

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

Undergoing radiation therapy

Primary Outcome Measure Information:

Title

Complete Response

Time Frame

5.5 weeks

Secondary Outcome Measure Information:

Title

Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1

Time Frame

5.5 weeks

Title

Median Time to Progression

Time Frame

5.5 weeks

Title

Quality of Life Improved Rate

Time Frame

5.5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound Bulk of gastroesophageal junction tumor should be in the esophagus Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors No known brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy > 4 months WBC > 4,000/mm³ ANC > 1,500/mm³ Platelet count > 100,000/mm³ Hemoglobin > 9 g/dL Bilirubin normal Creatinine normal AST < 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 3 times ULN Able to take oral medication or undergo enteral administration of medication No peripheral neuropathy ≥ grade 2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 90 days after completion of study treatment No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy No concurrent uncontrolled illness, including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situation that would preclude study compliance No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer Other cured tumors allowed at discretion of the principal investigator No known HIV or hepatitis B or C (active and/or previously treated) PRIOR CONCURRENT THERAPY: No prior therapy for esophageal cancer No other concurrent investigational agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nikhil Khushalani, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

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