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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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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 MedicineSeattle, Washington  98195
Seattle Cancer Care AllianceSeattle, Washington  98109