NCT00079079

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Oct 2003

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2009

Completed
Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

4.9 years

First QC Date

March 8, 2004

Last Update Submit

August 3, 2023

Conditions

Head and Neck Cancer

Keywords

stage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancersalivary gland acinic cell tumorsalivary gland adenoid cystic carcinomasalivary gland poorly differentiated carcinomahigh-grade salivary gland mucoepidermoid carcinomalow-grade salivary gland mucoepidermoid carcinomasalivary gland malignant mixed cell type tumorsalivary gland adenocarcinomasalivary gland anaplastic carcinomasalivary gland squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Toxicity assessed by NCI CTC v2.0

  • Overall survival

Interventions

carboplatinDRUG
cisplatinDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 19924794RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSalivary Gland Neoplasms

Interventions

CarboplatinCisplatinGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Lillian L. Siu, MD, FRCPC

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2004

First Posted

March 9, 2004

Study Start

October 27, 2003

Primary Completion

September 29, 2008

Study Completion

February 10, 2009

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)