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

Sponsored by:	Fred Hutchinson Cancer Research Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238147

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Drug: capecitabine Drug: carboplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy	Phase I

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Carboplatin Docetaxel Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	18
Study Start Date:	September 2004
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238147

Locations

United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
University of Washington School of Medicine
Seattle, Washington, United States, 98195

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

Investigators

Principal Investigator:

Sujata Rao, MD

Seattle Cancer Care Alliance

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Study ID Numbers:	CDR0000445238, UWCC-UW-6227, AVENTIS-UW-03031, ROCHE-UW-03031, UW-03031, UWCC-04-2311-D-01
Study First Received:	October 12, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00238147
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II esophageal cancer
stage III esophageal cancer

Study placed in the following topic categories:

Docetaxel
Capecitabine
Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Carboplatin
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009