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Cisplatin or Carboplatin Combined With Gemcitabine in 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 : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Tracking Information
First Submitted Date  ICMJE March 8, 2004
First Posted Date  ICMJE March 9, 2004
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE October 23, 2003
Actual Primary Completion Date September 29, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Objective response measured by RECIST criteria after accrual of 11 evaluable patients
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Toxicity assessed by NCI CTC v2.0
  • Overall survival
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
Official Title  ICMJE A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
34
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 10, 2009
Actual Primary Completion Date September 29, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00079079
Other Study ID Numbers  ICMJE HN4
CAN-NCIC-HN4
LILLY-CAN-NCIC-HN4
CDR0000353487 ( Other Identifier: PDQ )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
Study Sponsor  ICMJE NCIC Clinical Trials Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lillian L. Siu, MD, FRCPC Princess Margaret Hospital, Canada
PRS Account Canadian Cancer Trials Group
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP