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Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
capecitabine
carboplatin
docetaxel
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage II esophageal cancer, stage III esophageal cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed esophageal or gastroesophageal junction cancer Locally advanced disease, meeting 1 of the following staging criteria: T3, N0, M0 disease Any T, N1, M0 disease Measurable or evaluable disease PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic Bilirubin normal Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN) AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST/ALT normal Renal Creatinine ≤ 2.0 mg/dL Creatinine clearance ≥ 80 mL/min Cardiovascular No uncontrolled congestive heart failure No symptomatic coronary artery disease No uncontrolled arrhythmias No myocardial infarction within the past 12 months No other uncontrolled clinically significant cardiac disease Gastrointestinal Able to swallow tablets Intact upper gastrointestinal tract No malabsorption syndrome Immunologic No history of unanticipated severe reaction to fluoropyrimidine No known hypersensitivity to fluorouracil No severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No serious infection that requires continuous antibiotic therapy Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of seizures No history of serious psychiatric illness that would preclude study compliance or giving informed consent No peripheral neuropathy > grade 1 PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy Radiotherapy No prior radiotherapy Other More than 28 days since prior investigational drugs No concurrent warfarin for active anticoagulation

Sites / Locations

  • Seattle Cancer Care Alliance
  • University of Washington School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 12, 2005
Last Updated
May 15, 2013
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00238147
Brief Title
Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer
Official Title
Phase I Trial With Weekly Docetaxel, Capecitabine and Carboplatin as Induction Chemotherapy Followed by Concomitant Capecitabine and Radiotherapy in Patients With Locally Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer.
Detailed Description
OBJECTIVES: Primary Determine the maximum tolerated dose and dose-limiting toxicity of docetaxel when administered with carboplatin and capecitabine as neoadjuvant induction therapy in patients with locally advanced esophageal cancer. Secondary Determine the qualitative and quantitative toxic effects of this regimen in these patients. Determine the clinical and pathological response in these patients treated with neoadjuvant induction therapy comprising docetaxel, carboplatin, and capecitabine followed by chemoradiotherapy with capecitabine. OUTLINE: This is an open-label, dose-escalation study of docetaxel. Induction therapy: Patients receive docetaxel IV and carboplatin IV over 30-60 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 2 courses. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Approximately 7 days after completion of induction therapy, patients proceed to chemoradiotherapy. Chemoradiotherapy: Patients receive oral capecitabine twice daily on days 1-42 and undergo radiotherapy once daily, 5 days a week, on days 1-40. Surgery: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter. PROJECTED ACCRUAL: Approximately 18 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
stage II esophageal cancer, stage III esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed esophageal or gastroesophageal junction cancer Locally advanced disease, meeting 1 of the following staging criteria: T3, N0, M0 disease Any T, N1, M0 disease Measurable or evaluable disease PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic Bilirubin normal Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN) AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST/ALT normal Renal Creatinine ≤ 2.0 mg/dL Creatinine clearance ≥ 80 mL/min Cardiovascular No uncontrolled congestive heart failure No symptomatic coronary artery disease No uncontrolled arrhythmias No myocardial infarction within the past 12 months No other uncontrolled clinically significant cardiac disease Gastrointestinal Able to swallow tablets Intact upper gastrointestinal tract No malabsorption syndrome Immunologic No history of unanticipated severe reaction to fluoropyrimidine No known hypersensitivity to fluorouracil No severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No serious infection that requires continuous antibiotic therapy Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of seizures No history of serious psychiatric illness that would preclude study compliance or giving informed consent No peripheral neuropathy > grade 1 PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy Radiotherapy No prior radiotherapy Other More than 28 days since prior investigational drugs No concurrent warfarin for active anticoagulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujata Rao, MD
Organizational Affiliation
Seattle Cancer Care Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Rao S, Oelschlager BK, Koh WJ, et al.: Phase I trial with weekly docetaxel, capecitabine and carboplatin followed by concomitant capecitabine and radiotherapy in patients with locally advanced esophageal cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-123, 2008.
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Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer

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