Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002711
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL
Status:
COMPLETED
Status Verified Date:
2013-07
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 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 radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with cancer of the esophagus
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with cancer of the esophagus
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose and recommend a phase II dose for paclitaxel TAX when administered as a 96-hour intravenous infusion with a weekly fixed dose of intravenous cisplatin CDDP during concurrent radiotherapy for patients with localized esophageal cancer II Estimate the response rate of patients treated with 2 courses of TAXCDDP induction chemotherapy and the complete response rate of patients treated with TAXCDDP and concurrent radiotherapy III Describe the toxic effects of TAXCDDP prior to and during radiotherapy IV Describe the pharmacokinetics of TAX as a continuous infusion CI over 96 hours V Evaluate by flow cytometry the ability of CI TAX to block esophageal cancer cells in the G2-M phase of the cell cycle
OUTLINE After the MTD of TAX is reached on Part A new patients are entered on Part B The following acronyms are used CDDP Cisplatin NSC-119875 EBRT External-beam radiotherapy TAX Paclitaxel Bristol-Myers NSC-125973 PART A Radiotherapy plus 2-Drug Combination Chemotherapy EBRT using megavoltage equipment 10 MV recommended electron boost allowed for subclavicular fossae plus TAXCDDP PART B 2-Drug Combination Induction Chemotherapy followed by Radiotherapy plus 2-Drug Combination Chemotherapy TAXCDDP followed by EBRT as in Part A plus TAXCDDP
PROJECTED ACCRUAL At least 3 patientsdose will be entered on Part A up to 24 patients and 3-6 patients on Part B
OUTLINE After the MTD of TAX is reached on Part A new patients are entered on Part B The following acronyms are used CDDP Cisplatin NSC-119875 EBRT External-beam radiotherapy TAX Paclitaxel Bristol-Myers NSC-125973 PART A Radiotherapy plus 2-Drug Combination Chemotherapy EBRT using megavoltage equipment 10 MV recommended electron boost allowed for subclavicular fossae plus TAXCDDP PART B 2-Drug Combination Induction Chemotherapy followed by Radiotherapy plus 2-Drug Combination Chemotherapy TAXCDDP followed by EBRT as in Part A plus TAXCDDP
PROJECTED ACCRUAL At least 3 patientsdose will be entered on Part A up to 24 patients and 3-6 patients on Part B
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 |
|---|---|---|---|
| NCI-H95-0791 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064528 | REGISTRY | None | None |