A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors

NCIC Clinical Trials Group4 sites in 1 country34 target enrollmentOctober 27, 2003

ConditionsHead and Neck Cancer

Drugscarboplatin cisplatin gemcitabine hydrochloride

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: NCIC Clinical Trials Group
Enrollment: 34
Locations: 4
Primary Endpoint: Objective response measured by RECIST criteria after accrual of 11 evaluable patients
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with either cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor (cancer).

Detailed Description

OBJECTIVES: Primary * Determine the activity of cisplatin or carboplatin in combination with gemcitabine, in terms of response rate, in patients with locally advanced, recurrent, or metastatic malignant salivary gland tumor. Secondary * Determine the complete response in patients treated with these regimens. * Determine the duration of response in patients treated with these regimens. * Determine the toxicity profile of these regimens in these patients. * Determine the overall survival of patients treated with these regimens. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive either cisplatin IV over 1 hour on day 2 OR carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months thereafter until relapse. PROJECTED ACCRUAL: A total of 11- 34 patients will be accrued for this study within 1.5-3 years.

Registry

clinicaltrials.gov

Start Date

October 27, 2003

End Date

February 10, 2009

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group