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Status:

COMPLETED

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

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

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 ...

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 malig...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 27 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 10 2009

    Estimated Enrollment :

    34 Patients enrolled

    Trial Details

    Trial ID

    NCT00079079

    Start Date

    October 27 2003

    End Date

    February 10 2009

    Last Update

    August 4 2023

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    CancerCare Manitoba

    Winnipeg, Manitoba, Canada, R3E 0V9

    2

    London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, Canada, N6A 4L6

    3

    Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, Canada, K1H 8L6

    4

    Princess Margaret Hospital

    Toronto, Ontario, Canada, M5G 2M9