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

Sponsors and Collaborators:	Norris Cotton Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00014417

Purpose

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	Intervention	Phase
Esophageal Cancer	Drug: capecitabine Drug: carboplatin Drug: docetaxel 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
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

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

Primary Outcome Measures:

Safely tolerate maximum dose defined as < 33% dose limiting toxicity at completion of treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response rate as measured by radiographic and pathologic response at the completion of treatment [ Designated as safety issue: No ]
Resection rate as measured by a R0 vs R1 resection [ Designated as safety issue: No ]
Response duration as measured by progression-free survival at median time to progression or death [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2000

Detailed Description:

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014417

Locations

United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu

Sponsors and Collaborators

Norris Cotton Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

James R. Rigas, MD

Norris Cotton Cancer Center

More Information

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

Study ID Numbers:	CDR0000068542, DMS-9939, NCI-G01-1931
Study First Received:	April 10, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00014417
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II esophageal cancer
stage III esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Squamous cell carcinoma
Carboplatin
Carcinoma
Docetaxel

Epidermoid carcinoma
Digestive System Diseases
Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
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 16, 2009