search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
carboplatin
cisplatin
gemcitabine hydrochloride
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenoid cystic carcinoma, salivary gland poorly differentiated carcinoma, high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, salivary gland malignant mixed cell type tumor, salivary gland adenocarcinoma, salivary gland anaplastic carcinoma, salivary gland squamous cell carcinoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant salivary gland tumor All histological subtypes eligible Locally advanced, recurrent, or metastatic disease Considered incurable by radiotherapy or surgery Low- to intermediate-grade mucoepidermoid tumor or acinic cell carcinoma allowed provided patients are symptomatic OR at imminent risk of developing symptoms attributable to metastatic disease Disease must meet 1 of the following criteria: Metastatic disease that is chemonaïve Metastatic disease that has progressed after a prior non-cisplatin/carboplatin/gemcitabine regimen Local and/or distant recurrence after curative surgery and/or radiotherapy Locally advanced disease not suitable for surgery or radiotherapy At least 1 site of unidimensionally measurable disease documented by 1 of the following: At least 20 mm by X-ray, physical exam, or non-spiral CT scan At least 10 mm by spiral CT scan No bone metastases as only site of measurable disease No known brain metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST/ALT no greater than 3 times upper limit of normal Renal Creatinine clearance at least 60 mL/min (for cisplatin) OR 30-59 mL/min (for carboplatin) Cardiovascular No symptomatic congestive heart failure No unstable angina No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious illness or medical condition that would preclude study participation No active uncontrolled infection No neurologic disorder or psychiatric illness that would preclude study compliance No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy for locally advanced, recurrent, or metastatic disease and recovered Must have been a non-cisplatin/carboplatin/gemcitabine-containing regimen More than 12 months since prior adjuvant chemotherapy (including cisplatin/carboplatin-based regimens) and recovered No prior gemcitabine Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to only site of measurable disease unless there is documented disease progression after therapy Surgery See Disease Characteristics At least 21 days since prior surgery and recovered Other More than 30 days since prior anticancer therapy More than 30 days since prior investigational agents No other concurrent anticancer therapy No other concurrent investigational agents

Sites / Locations

  • CancerCare Manitoba
  • London Regional Cancer Program at London Health Sciences Centre
  • Ottawa Hospital Regional Cancer Centre - General Campus
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Objective response measured by RECIST criteria after accrual of 11 evaluable patients

Secondary Outcome Measures

Toxicity assessed by NCI CTC v2.0
Overall survival

Full Information

First Posted
March 8, 2004
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00079079
Brief Title
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
Official Title
A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 27, 2003 (Actual)
Primary Completion Date
September 29, 2008 (Actual)
Study Completion Date
February 10, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage II salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland acinic cell tumor, salivary gland adenoid cystic carcinoma, salivary gland poorly differentiated carcinoma, high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, salivary gland malignant mixed cell type tumor, salivary gland adenocarcinoma, salivary gland anaplastic carcinoma, salivary gland squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Objective response measured by RECIST criteria after accrual of 11 evaluable patients
Secondary Outcome Measure Information:
Title
Toxicity assessed by NCI CTC v2.0
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant salivary gland tumor All histological subtypes eligible Locally advanced, recurrent, or metastatic disease Considered incurable by radiotherapy or surgery Low- to intermediate-grade mucoepidermoid tumor or acinic cell carcinoma allowed provided patients are symptomatic OR at imminent risk of developing symptoms attributable to metastatic disease Disease must meet 1 of the following criteria: Metastatic disease that is chemonaïve Metastatic disease that has progressed after a prior non-cisplatin/carboplatin/gemcitabine regimen Local and/or distant recurrence after curative surgery and/or radiotherapy Locally advanced disease not suitable for surgery or radiotherapy At least 1 site of unidimensionally measurable disease documented by 1 of the following: At least 20 mm by X-ray, physical exam, or non-spiral CT scan At least 10 mm by spiral CT scan No bone metastases as only site of measurable disease No known brain metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST/ALT no greater than 3 times upper limit of normal Renal Creatinine clearance at least 60 mL/min (for cisplatin) OR 30-59 mL/min (for carboplatin) Cardiovascular No symptomatic congestive heart failure No unstable angina No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious illness or medical condition that would preclude study participation No active uncontrolled infection No neurologic disorder or psychiatric illness that would preclude study compliance No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy for locally advanced, recurrent, or metastatic disease and recovered Must have been a non-cisplatin/carboplatin/gemcitabine-containing regimen More than 12 months since prior adjuvant chemotherapy (including cisplatin/carboplatin-based regimens) and recovered No prior gemcitabine Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to only site of measurable disease unless there is documented disease progression after therapy Surgery See Disease Characteristics At least 21 days since prior surgery and recovered Other More than 30 days since prior anticancer therapy More than 30 days since prior investigational agents No other concurrent anticancer therapy No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lillian L. Siu, MD, FRCPC
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Hospital Regional Cancer Centre - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19924794
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs