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

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).

Timeline

Start

2003-10-27

Primary completion

2008-09-29

Completion

2009-02-10

Outcome

Missed primary endpoint

paper Eight objective responses were observed (1 complete and 7 partial) for a response rate of 24% (95% confidence interval, 11-42%), PMID 19924794 ↗

paper This regimen did not meet the predefined criteria to be declared active in advanced salivary gland cancers. PMID 19924794 ↗

Publications

• Results Laurie SA, Siu LL, Winquist E, Maksymiuk A, Harnett EL, Walsh W, Tu D, Parulekar WR. A phase 2 study of platinum and gemcitabine in patients with advanced salivary gland cancer: a trial of the NCIC Clinical Trials Group. Cancer. 2010 Jan 15;116(2):362-8. doi: 10.1002/cncr.24745.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Indications