Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer
Information source: Dartmouth-Hitchcock Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Esophageal Neoplasms
Intervention: Capecitabine (Xeloda) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Dartmouth-Hitchcock Medical Center Official(s) and/or principal investigator(s):
James R Rigas, MD, Principal Investigator, Affiliation: Norris Cotton Cancer Center
Overall contact:
James R Rigas, MD, Phone: 603-650-6344, Email: James.R.Rigas@Dartmouth.Edu
Summary
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.To determine the reliability of clinical staging and antitumor response rate assessment using endoscopic ultrasound. To investigate the feasibility of assaying thymidine phosphorylase, cyclin B, MPM-2, and perturbations in cell cycle as potential markers of efficacy.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
James R Rigas, MD, Phone: 603-650-6344, Email: James.R.Rigas@Dartmouth.Edu
Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States; Recruiting
James R Rigas, MD, Principal Investigator
Additional Information
Norris Cotton Cancer Center Home Page
Starting date: February 2000
Ending date: December 2012
Last updated: May 20, 2009
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