Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer - Full Text View

Sponsor:	Dartmouth-Hitchcock Medical Center
Collaborators:	Sanofi-Aventis Hoffmann-La Roche
Information provided by (Responsible Party):	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00153881

Purpose

The primary objective is to determine the maximum tolerated dose of oral capecitabine, in combination with fixed doses of weekly docetaxel, and concurrent thoracic radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction.

Condition	Intervention	Phase
Esophageal Neoplasms	Drug: Capecitabine (Xeloda)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Carboplatin Docetaxel Capecitabine

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

To determine the maximum tolerated dose of oral capecitabine in combination with fixed doses of weekly docetaxel and concurrent radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction. [ Time Frame: Enrollment of first subject to accural of last subject/ and data analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine clinical and pathological response rate, rate of resectability, duration of response, and patterns of failure for patients with esophageal and gastroesophageal junction cancers. [ Time Frame: Enrollment of first subject to accrual of last subject/ data analysis ] [ Designated as safety issue: No ]
To determine the reliability of clinical staging and antitumor response rate assessment using endoscopic ultrasound. [ Time Frame: Enrollment of first subject to accrual of last subject/ data analysis of study. ] [ Designated as safety issue: No ]
To investigate the feasibility of assaying thymidine phosphorylase, cyclin B, MPM-2, and perturbations in cell cycle as potential markers of efficacy. [ Time Frame: Enrollment of first subject to accrual of last/ data analysis of study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	February 2000
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Docetaxel/Carboplatin every 3 weeks for 2 cycles then concommitant chemotherapy and radiation Docetaxel weekly for 5 doses without premedication, then Capecitabine will be given orally, one dose prior to each fraction or irradiation (28 cycles).	Drug: Capecitabine (Xeloda) Neoadjuvant Chemotherapy: Docetaxel every 3 weeks for 2 cycles Carboplatin every 3 weeks for 2 cycles with prophylactic antibiotics and antiemetics as needed. Concomitant chemotherapy and radiation: Docetaxel weekly for 5 doses without premedication Capecitabine orally, one dose prior to each fraction of irradiation (28 cycles). Other Names: Capecitabine Carboplatin Docetaxel

Arms

Assigned Interventions

Experimental: 1

Docetaxel/Carboplatin every 3 weeks for 2 cycles then concommitant chemotherapy and radiation Docetaxel weekly for 5 doses without premedication, then Capecitabine will be given orally, one dose prior to each fraction or irradiation (28 cycles).

Drug: Capecitabine (Xeloda)

Neoadjuvant Chemotherapy:

Docetaxel every 3 weeks for 2 cycles Carboplatin every 3 weeks for 2 cycles with prophylactic antibiotics and antiemetics as needed.

Concomitant chemotherapy and radiation:

Docetaxel weekly for 5 doses without premedication Capecitabine orally, one dose prior to each fraction of irradiation (28 cycles).

Other Names:

Capecitabine
Carboplatin
Docetaxel

Detailed Description:

This dose-ranging trial is designed to establish the phase II dose of capecitabine that can safely be given with docetaxel and radiation therapy for the treatment of patients with cancer of the esophagus and gastroesophageal junction. The docetaxel dose of 15 mg/m2/week, 5-fluorouracil dose of 200 mg/m2/week, and 50.4 Gy of thoracic radiation has been found to be the recommended doses from our initial phase I trial (DMS D9724). The Phase I study has been modified in an attempt to improve the pathological complete response rate by increasing the 5-fluorouracil exposure during thoracic radiation by replacing it with oral capecitabine. Capecitabine generates 5-fluorouracil selectively in tumor cells. This sequentially designed study of EUS staging, molecular analysis, neoadjuvant chemotherapy, concomitant chemotherapy and radiation, and surgical resection continues to expand our collaborative experience at Dartmouth Hitchcock in the treatment of cancer of the esophagus and gastroesophageal junction.

Eligibility

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

Criteria

Inclusion Criteria:

Esophageal or gastroesophageal junction cancer that is locally advanced and surgically resectable (stage II or III disease).
No prior therapy.
Adequate organ function.

Exclusion Criteria:

Evidence of metastasis (celiac axis lymph nodes are allowed).
Cervical esophageal tumors.
Peripheral or auditory neuropathy grade >= 2.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153881

Locations

United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Sanofi-Aventis

Hoffmann-La Roche

Investigators

Principal Investigator:

James R Rigas, MD

Norris Cotton Cancer Center

More Information

Additional Information:

Norris Cotton Cancer Center Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00153881 History of Changes
Obsolete Identifiers:	NCT00014417
Other Study ID Numbers:	D-9939
Study First Received:	September 7, 2005
Last Updated:	October 19, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

Esophageal Cancer
Trimodality
Capecitabine

Xeloda
Gastro-esophageal Neoplasm
Carcinoma of the Esophagus

Additional relevant MeSH terms:

Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Docetaxel
Capecitabine

Carboplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012