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Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Hoffmann-La Roche
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00153881
First received: September 7, 2005
Last updated: November 11, 2014
Last verified: November 2014
  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 1

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:


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 ]

Enrollment: 44
Study Start Date: February 2000
Study Completion Date: September 2013
Primary Completion Date: September 2013 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hoffmann-La Roche
Investigators
Principal Investigator: James R Rigas, MD Norris Cotton Cancer Center
  More Information

Additional Information:
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: November 11, 2014
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:
Esophageal Neoplasms
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Capecitabine
Carboplatin
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014