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

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153881
• Other study ID #: D-9939
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2005
• Last updated: November 11, 2014
• Start date: February 2000
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00014417

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Hoffmann-La Roche, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Enrollment of first subject to accural of last subject/ and data analysis	No
Secondary	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.		Enrollment of first subject to accrual of last subject/ data analysis	No
Secondary	To determine the reliability of clinical staging and antitumor response rate assessment using endoscopic ultrasound.		Enrollment of first subject to accrual of last subject/ data analysis of study.	No
Secondary	To investigate the feasibility of assaying thymidine phosphorylase, cyclin B, MPM-2, and perturbations in cell cycle as potential markers of efficacy.		Enrollment of first subject to accrual of last/ data analysis of study.	No

External Links

•   Norris Cotton Cancer Center Home Page