Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	NCI	DMS-9939 NCI-G01-1931, NCT00014417

Objectives

1. 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.
2. Determine the clinical and pathological response rate, rate of resectability, duration of response, patterns of failure, and survival of patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Safely tolerate maximum dose defined as < 33% dose limiting toxicity at completion of treatment

Response rate as measured by radiographic and pathologic response at the completion of treatment
Resection rate as measured by a R0 vs R1 resection
Response duration as measured by progression-free survival at median time to progression or death

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.

Trial Contact Information

Trial Lead Organizations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

James Rigas, MD, Protocol chair		Ph: 603-650-6344; 800-639-6918 Email: james.r.rigas@dartmouth.edu

U.S.A.
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu

Registry Information
Official Title		Docetaxel And Carboplatin Followed By A Dose-Ranging Study Of Oral Capecitabine, Weekly Docetaxel, And Concomitant External Beam Radiotherapy For The Treatment Of Patients With Stage II-III Carcinoma Of The Esophagus And Gastro-Esophageal Junction
Trial Start Date		2000-06-01
Registered in ClinicalTrials.gov		NCT00014417
Date Submitted to PDQ		2001-02-07
Information Last Verified		2007-05-27
NCI Grant/Contract Number		CA23108

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