Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002984
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced or Metastatic Cancer of the Esophagus
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Paclitaxel Combined With 5-FU and Cisplatin Concomitant With Radiotherapy in the Management of Locally Advanced or Metastatic Esophageal Cancer Adenocarcinoma and Squamous Histologies - A Phase IModified Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-05
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 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 more than on drug and combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with advanced or metastatic cancer of the esophagus
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with advanced or metastatic cancer of the esophagus
Detailed Description:
OBJECTIVES I Define the maximum tolerated dose MTD of paclitaxel TAX when given as a 3 hour infusion in combination with cisplatin CDDP fluorouracil 5-FU and radiation therapy II Define the toxicity profile of TAX when given as a 3 hour infusion in combination with CDDP 5-FU and radiation therapy III Evaluate the effectiveness of a TAX containing chemotherapy regimen and concurrent radiotherapy followed by resection in the treatment of locally advanced esophageal cancer as judged by the complete response rate pathological complete response rate time to recurrence and overall survival
OUTLINE Patients receive radiation to the tumor and nodal area 5 days a week for 5 weeks Patients receive chemotherapy consisting of cisplatin CDDP via rapid intravenous infusion on day 1 followed by fluorouracil 5-FU via 96-hour continuous infusion CI on days 1 through 4 this is repeated on the last 4 days of radiation therapy days 29-31 with an additional dose of CDDP on day 29 and a 96-hour CI of 5-FU on days 29-31 Patients also receive paclitaxel TAX as a weekly 3 hour infusion on days 1 8 15 and 29 with 3 patients treated at each dose level and subsequent patients treated according to the toxicity observed in previous cohorts TAX will be given prior to the CDDP and 5-FU on the weeks when it is given concurrently The MTD of TAX is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity Surgical resection takes place 2-8 weeks following completion of chemoradiotherapy in all patients except those with disease progression and those who are surgically unresectable or medically unfit includes those with metastatic disease to tolerate surgery An additional course of TAXCDDP5-FU is given 28-35 days after surgery
PROJECTED ACCRUAL Three patients will be entered into the lowest dose level of TAX and 3-6 patients entered into up to three additional dose levels of TAX for the phase I study An additional group of up to 11 patients will be accrued for the first stage of the modified phase II study and 38 to the second stage if warranted The study will be completed within 3-4 years
OUTLINE Patients receive radiation to the tumor and nodal area 5 days a week for 5 weeks Patients receive chemotherapy consisting of cisplatin CDDP via rapid intravenous infusion on day 1 followed by fluorouracil 5-FU via 96-hour continuous infusion CI on days 1 through 4 this is repeated on the last 4 days of radiation therapy days 29-31 with an additional dose of CDDP on day 29 and a 96-hour CI of 5-FU on days 29-31 Patients also receive paclitaxel TAX as a weekly 3 hour infusion on days 1 8 15 and 29 with 3 patients treated at each dose level and subsequent patients treated according to the toxicity observed in previous cohorts TAX will be given prior to the CDDP and 5-FU on the weeks when it is given concurrently The MTD of TAX is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity Surgical resection takes place 2-8 weeks following completion of chemoradiotherapy in all patients except those with disease progression and those who are surgically unresectable or medically unfit includes those with metastatic disease to tolerate surgery An additional course of TAXCDDP5-FU is given 28-35 days after surgery
PROJECTED ACCRUAL Three patients will be entered into the lowest dose level of TAX and 3-6 patients entered into up to three additional dose levels of TAX for the phase I study An additional group of up to 11 patients will be accrued for the first stage of the modified phase II study and 38 to the second stage if warranted The study will be completed within 3-4 years
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-G97-1240 | None | None | None |
| CDR0000065519 | None | None | None |