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
18 Years
N/A
Both
Esophageal Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Sujata Rao, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seattle Cancer Care Alliance
Authority:
United States: Federal Government
Study ID:
6227
NCT ID:
NCT00238147
Start Date:
September 2004
Completion Date:
August 2008
Related Keywords:
- Esophageal Cancer
- stage II esophageal cancer
- stage III esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| University of Washington School of Medicine | Seattle, Washington 98195 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
