Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281788
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2006-01-24
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase I Study of Oral Capecitabine in Combination With Weekly IV CarboplatinPaclitaxel and Radiation Therapy for Patients
Status:
COMPLETED
Status Verified Date:
2008-04
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 capecitabine carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving chemotherapy together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin paclitaxel and radiation therapy in treating patients with esophageal cancer or gastroesophageal junction cancer
PURPOSE This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin paclitaxel and radiation therapy in treating patients with esophageal cancer or gastroesophageal junction cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and recommended phase II dose of capecitabine when administered with carboplatin paclitaxel and radiotherapy in patients with carcinoma of the esophagus or gastroesophageal junction
Secondary
Determine the radiographic and pathologic response rate in patients treated with this regimen
Correlate preliminarily tumor biomarker response with clinical response in patients treated with this regimen
OUTLINE This is an open-label dose-escalation study of capecitabine
Patients undergo radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 and carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on day 2 Treatment repeats weekly for 5 weeks in the absence of disease progression or unacceptable toxicity Beginning at week 9 4 weeks after completing chemoradiotherapy some patients may undergo surgery to remove the tumor Patients with unresectable or gross residual disease after completing radiotherapy may continue to receive capecitabine carboplatin and paclitaxel for as long as the chemotherapy is beneficial
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 preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Primary
Determine the maximum tolerated dose and recommended phase II dose of capecitabine when administered with carboplatin paclitaxel and radiotherapy in patients with carcinoma of the esophagus or gastroesophageal junction
Secondary
Determine the radiographic and pathologic response rate in patients treated with this regimen
Correlate preliminarily tumor biomarker response with clinical response in patients treated with this regimen
OUTLINE This is an open-label dose-escalation study of capecitabine
Patients undergo radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 and carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on day 2 Treatment repeats weekly for 5 weeks in the absence of disease progression or unacceptable toxicity Beginning at week 9 4 weeks after completing chemoradiotherapy some patients may undergo surgery to remove the tumor Patients with unresectable or gross residual disease after completing radiotherapy may continue to receive capecitabine carboplatin and paclitaxel for as long as the chemotherapy is beneficial
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 preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 36 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 |
|---|---|---|---|
| CDR0000449942 | OTHER | NCI | None |
| DUMC-4950-05-8R2 | None | None | None |