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| Descriptive Information Fields | |||||
| Brief Title † | Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus | ||||
| 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 | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage II or stage III cancer of the esophagus. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study of capecitabine. Patients receive neoadjuvant docetaxel IV over 1 hour on day 1 of weeks 1 and 4 and carboplatin IV over 30 minutes on day 2 of week 1 and day 1 of week 4. Beginning at week 7, patients undergo external beam radiotherapy once daily 5 days a week for 28 days. Patients also receive concurrent docetaxel IV over 15-30 minutes once weekly for 5 weeks and oral capecitabine once daily for 28 days. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity. Patients are followed at week 15, at least every 6-9 weeks for 6 months, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 8-12 months. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | Safely tolerate maximum dose defined as < 33% dose limiting toxicity at completion of treatment [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | Response rate as measured by radiographic and pathologic response at the completion of treatment [ Designated as safety issue: No ] Resection rate as measured by a R0 vs R1 resection [ Designated as safety issue: No ] Response duration as measured by progression-free survival at median time to progression or death [ Designated as safety issue: No ] |
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| Condition † | Esophageal Cancer | ||||
| Intervention † | Drug: capecitabine Drug: carboplatin Drug: docetaxel Procedure: neoadjuvant therapy Procedure: radiation therapy |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 24 | ||||
| Start Date † | June 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00014417 | ||||
| Organization ID | CDR0000068542 | ||||
| Secondary IDs †† | DMS-9939, NCI-G01-1931 | ||||
| Study Sponsor † | Norris Cotton Cancer Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2007 | ||||
| First Received Date † | April 10, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||