NCT00701857

Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	Standard weekly dose
DRUG	Pemetrexed	Biweekly pemetrexed dose escalation
RADIATION	radiation therapy	Weekly standard dose radiation therapy

Timeline

• Start date: 2008-02-01
• Primary completion: 2014-04-01
• Completion: 2015-09-01
• First posted: 2008-06-19
• Last updated: 2016-04-20

Locations

1 site across 1 country: United States