Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic … (NCT00079079) | Clinical Trial Compass
CompletedPhase 2
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
Canada34 participantsStarted 2003-10-27
Plain-language 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).
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Objective response measured by RECIST criteria after accrual of 11 evaluable patients