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

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ClinicalTrials.gov Identifier: NCT00079079

Recruitment Status : Completed

First Posted : March 9, 2004

Last Update Posted : April 6, 2020

Sponsor:

Information provided by (Responsible Party):

Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

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).

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors
Actual Study Start Date :	October 23, 2003
Actual Primary Completion Date :	September 29, 2008
Actual Study Completion Date :	February 10, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Salivary Gland Cancer

Drug Information available for: Cisplatin Carboplatin Gemcitabine Gemcitabine hydrochloride

Genetic and Rare Diseases Information Center resources: Adenoid Cystic Carcinoma Mucoepidermoid Carcinoma Acinic Cell Carcinoma Oral Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 120 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079079

Locations

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Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

NCIC Clinical Trials Group

Investigators

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Study Chair:	Lillian L. Siu, MD, FRCPC	Princess Margaret Hospital, Canada

More Information

Publications of 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.

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Responsible Party:	NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:	NCT00079079
Other Study ID Numbers:	HN4 CAN-NCIC-HN4 ( Other Identifier: PDQ ) LILLY-CAN-NCIC-HN4 ( Other Identifier: LILLY ) CDR0000353487 ( Other Identifier: PDQ )
First Posted:	March 9, 2004 Key Record Dates
Last Update Posted:	April 6, 2020
Last Verified:	April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):


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 malignant mixed cell type 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 adenocarcinoma salivary gland anaplastic carcinoma salivary gland squamous cell carcinoma

Additional relevant MeSH terms:

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Salivary Gland Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Gemcitabine Cisplatin Carboplatin	Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

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