Clinical Trial: Cisplatin or Carboplatin Combined With Gemcitabine in Treating Patients With Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: NCIC Clinical Trials Group

Current Primary Outcome: Objective response measured by RECIST criteria after accrual of 11 evaluable patients

Original Primary Outcome:

Current Secondary Outcome:

  • Toxicity assessed by NCI CTC v2.0
  • Overall survival


Original Secondary Outcome:

Information By: Canadian Cancer Trials Group

Dates:
Date Received: March 8, 2004
Date Started: October 2003
Date Completion:
Last Updated: November 25, 2016
Last Verified: March 2010