Docetaxel and Carboplatin Followed by Oral Capecitabine, Docetaxel and Radiation for Esophageal Cancer
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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 |
- 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 ]
- 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: | June 2013 |
| Estimated Primary Completion Date: | May 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:
|
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 |
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| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| 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: | January 8, 2013 |
| 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 June 18, 2013