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

NCT00153881 | Completed Phase 1 DMC

• 1 other identifier: D-9939
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Neoplasms

Keywords

Esophageal Cancer; Trimodality; Capecitabine; Xeloda; Gastro-esophageal Neoplasm; Carcinoma of the Esophagus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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.

• 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.

Study Arms (1)

1

EXPERIMENTAL

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)

Interventions

Capecitabine (Xeloda) DRUG

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).

Also known as: Capecitabine, Carboplatin, Docetaxel

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Sanofi: collaborator
• Hoffmann-La Roche: collaborator

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Capecitabine; Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• James R Rigas, MD

  Norris Cotton Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2000
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

US (1)