RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.

Condition	Treatment or Intervention	Phase
stage II esophageal cancer stage III esophageal cancer squamous cell carcinoma of the esophagus Adenocarcinoma of the Esophagus	Drug: capecitabine  Drug: carboplatin  Drug: docetaxel  Procedure: chemotherapy  Procedure: neoadjuvant therapy  Procedure: radiation therapy	Phase I

Further Study Details: 

OBJECTIVES:

• Determine the maximum tolerated dose of capecitabine when administered with docetaxel and concurrent external beam radiotherapy following neoadjuvant docetaxel and carboplatin in patients with stage II or III carcinoma of the esophagus or gastroesophageal junction.
• Determine the clinical and pathological response rate, rate of resectability, duration of response, patterns of failure, and survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of capecitabine.

Patients receive neoadjuvant docetaxel IV over 1 hour on day 1 of weeks 1 and 4 and carboplatin IV over 30 minutes on day 2 of week 1 and day 1 of week 4.

Beginning at week 7, patients undergo external beam radiotherapy once daily 5 days a week for 28 days. Patients also receive concurrent docetaxel IV over 15-30 minutes once weekly for 5 weeks and oral capecitabine once daily for 28 days.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity.

Patients are followed at week 15, at least every 6-9 weeks for 6 months, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 8-12 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
• Locally advanced and surgically resectable stage II or III disease (T2-4, N0, M0 or T1-4, N1, M0)
• Bulk of tumor must involve the esophagus or gastroesophageal junction if tumor extends below the gastroesophageal junction into the proximal stomach
• No clinical evidence of metastasis to cervical or supraclavicular lymph nodes
• Celiac axis lymph node metastases in gastroesophageal junction cancer allowed
• No cervical esophageal tumor
• No recurrent laryngeal nerve or phrenic nerve paralysis
• No gastric cancer with only minor involvement of the gastroesophageal junction or distal esophagus
• No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
• No brain, bone, pulmonary, or liver metastases
• No positive pleural, pericardial, or peritoneal cytology

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)
• AST or ALT no greater than 5 times ULN
• Alkaline phosphatase no greater than 5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance greater than 50 mL/min
• Calcium no greater than 12 mg/dL

Other:

• No grade 2 or greater peripheral or auditory neuropathy
• No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
• No serious infection or nonmalignant medical illness
• No psychiatric disorder that would preclude study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior immunotherapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior chest or abdominal radiotherapy

Surgery:

• Not specified

New Hampshire
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States; Recruiting

Study chairs or principal investigators

James R. Rigas, MD,  Study Chair,  Norris Cotton Cancer Center   

Study ID Numbers:  CDR0000068542; DMS-9939; NCI-G01-1931; NCT00014417
Record last reviewed:  April 2001
Last Updated:  December 6, 2004
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014417
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08