Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 5:39 PM
Study NCT ID:
NCT00701857
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2008-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
Phase I Study of Concomitant Pemetrexed and CDDP Plus Radiation Therapy in Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal (GEJ) Carcinomas
Status:
COMPLETED
Status Verified Date:
2016-04
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: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, 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. Cisplatin may make tumor cells more sensitive to radiation therapy. Giving pemetrexed together with cisplatin and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with cisplatin and radiation therapy in treating patients with stage III or stage IV esophageal cancer or gastroesophageal junction cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with cisplatin and radiation therapy in treating patients with stage III or stage IV esophageal cancer or gastroesophageal junction cancer.
Detailed Description:
OBJECTIVES:
Primary
* To establish the maximum tolerated dose of pemetrexed disodium in combination with cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or gastroesophageal junction carcinoma.
Secondary
* To specifically characterize the toxicity profile of this regimen.
* To investigate, preliminarily, the anti-tumor activity of this regimen, as measured by standard response criteria (RECIST criteria), in patients with measurable disease.
OUTLINE: This is a dose-escalation study of pemetrexed disodium.
Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and cisplatin IV over 10 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external beam radiotherapy once daily, 5 days a week, for up to 6 weeks.
After completion of study therapy, patients are followed for 30 days and then every 3 months for 1 year.
Primary
* To establish the maximum tolerated dose of pemetrexed disodium in combination with cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or gastroesophageal junction carcinoma.
Secondary
* To specifically characterize the toxicity profile of this regimen.
* To investigate, preliminarily, the anti-tumor activity of this regimen, as measured by standard response criteria (RECIST criteria), in patients with measurable disease.
OUTLINE: This is a dose-escalation study of pemetrexed disodium.
Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and cisplatin IV over 10 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external beam radiotherapy once daily, 5 days a week, for up to 6 weeks.
After completion of study therapy, patients are followed for 30 days and then every 3 months for 1 year.
Study Oversight
Has Oversight DMC:
True
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?: