NCT00079079

Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cisplatin
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2003-10-27
• Primary completion: 2008-09-29
• Completion: 2009-02-10
• First posted: 2004-03-09
• Last updated: 2023-08-04

Locations

4 sites across 1 country: Canada