Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
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.
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The maximum tolerated dose (MTD) of pemetrexed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Toxicity profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||September 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Pemetrexed, Cisplatin, Radiation Therapy
Concomitant Pemetrexed and CDDP Plus Radiation Therapy
Standard weekly dose
Other Name: CDDPDrug: Pemetrexed
Biweekly pemetrexed dose escalation
Other Name: Pemetrexed disodiumRadiation: radiation therapy
Weekly standard dose radiation therapy
Other Name: RT
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701857
|United States, Arizona|
|University of Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Emad Elquza, MD||University of Arizona|