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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00079079
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Description
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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)
Estimated Enrollment : 34 participants
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
Study Start Date : October 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Objective response measured by RECIST criteria after accrual of 11 evaluable patients

Secondary Outcome Measures :
  1. Toxicity assessed by NCI CTC v2.0
  2. 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
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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
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Publications of Results:

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Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00079079    
Other Study ID Numbers: HN4
CAN-NCIC-HN4
LILLY-CAN-NCIC-HN4
CDR0000353487 ( Other Identifier: PDQ )
First Posted: March 9, 2004    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: March 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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