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A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

2014-08-27 03:42:14 | BioPortfolio

Summary

This is a study of an investigational agent, pemetrexed, in combination with a standard chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.

Description

All patients will have the following pre-study evaluations:

- complete medical history and physical examination

- magnetic resonance imaging (MRI) scan or computed tomography (CT) scan

- blood tests (about 3-4 tablespoons of blood will be drawn to conduct standard laboratory tests)

If they are eligible and agree to participate, they will need to take the following premedications:

- Folic acid in tablet form (taken at home) once a day beginning approximately 5-7 days before chemotherapy and continuing until 3 weeks after last treatment;

- Vitamin B12 as an injection (given in clinic) approximately 1-2 weeks before first chemotherapy treatment and repeated approximately every 9 weeks until 3 weeks after last treatment;

- Dexamethasone in tablet form (taken at home) twice daily on the day before, the day of, and the day after each dose of chemotherapy.

Patients will complete a pill diary to monitor compliance with pre-medications.

Treatment will consist of pemetrexed through an intravenous (i.v.) injection for 10 minutes, followed by carboplatin through an i.v. injection for 30 minutes. Participants will receive this treatment in the clinic every 3 weeks (one cycle) as long as the disease responds or does not get worse, for a maximum of 6 cycles.

During treatment, participants will be evaluated every 2 cycles (every 6 weeks) with CT scans and/or MRI scans, to see whether their disease is getting better. In addition, weekly blood will be drawn for safety purposes.

At end of study, the CT or MRI scans and blood tests will be repeated.

We expect that participants will be in the study for approximately 20 weeks (4-5 months.) If the cancer gets worse at any time while they are on the study, participants will be removed from the study and offered other treatment. Once treatment ends, participants will be asked to return to the clinic for blood tests and a physical exam every 2 months for 6 months, then every 3 months for 1 year, and every 6 months thereafter.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Esophageal Neoplasms

Intervention

pemetrexed, carboplatin

Location

Washington University School of Medicine
St. Louis
Missouri
United States
63110

Status

Terminated

Source

Washington University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:14-0400

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