Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238147
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2005-10-12
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase I Trial With Weekly Docetaxel Capecitabine and Carboplatin as Induction Chemotherapy Followed by Concomitant Capecitabine and Radiotherapy in Patients With Locally Advanced Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as docetaxel carboplatin and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays to kill tumor cells Capecitabine may also make tumor cells more sensitive to radiation therapy Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of docetaxel when administered with carboplatin and capecitabine as neoadjuvant induction therapy in patients with locally advanced esophageal cancer
Secondary
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the clinical and pathological response in these patients treated with neoadjuvant induction therapy comprising docetaxel carboplatin and capecitabine followed by chemoradiotherapy with capecitabine
OUTLINE This is an open-label dose-escalation study of docetaxel
Induction therapy Patients receive docetaxel IV and carboplatin IV over 30-60 minutes on days 1 8 and 15 and oral capecitabine twice daily on days 1-21 Treatment repeats every 28 days for 2 courses
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Approximately 7 days after completion of induction therapy patients proceed to chemoradiotherapy
Chemoradiotherapy Patients receive oral capecitabine twice daily on days 1-42 and undergo radiotherapy once daily 5 days a week on days 1-40
Surgery Approximately 4-8 weeks after completion of chemoradiotherapy patients undergo surgery
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 18 patients will be accrued for this study
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of docetaxel when administered with carboplatin and capecitabine as neoadjuvant induction therapy in patients with locally advanced esophageal cancer
Secondary
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the clinical and pathological response in these patients treated with neoadjuvant induction therapy comprising docetaxel carboplatin and capecitabine followed by chemoradiotherapy with capecitabine
OUTLINE This is an open-label dose-escalation study of docetaxel
Induction therapy Patients receive docetaxel IV and carboplatin IV over 30-60 minutes on days 1 8 and 15 and oral capecitabine twice daily on days 1-21 Treatment repeats every 28 days for 2 courses
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Approximately 7 days after completion of induction therapy patients proceed to chemoradiotherapy
Chemoradiotherapy Patients receive oral capecitabine twice daily on days 1-42 and undergo radiotherapy once daily 5 days a week on days 1-40
Surgery Approximately 4-8 weeks after completion of chemoradiotherapy patients undergo surgery
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 18 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000445238 | REGISTRY | PDQ | None |
| UWCC-UW-6227 | None | None | None |
| AVENTIS-UW-03031 | None | None | None |
| ROCHE-UW-03031 | None | None | None |
| UW-03031 | None | None | None |
| UWCC-04-2311-D-01 | None | None | None |