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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: cisplatin
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response measured by RECIST criteria after accrual of 11 evaluable patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity assessed by NCI CTC v2.0 |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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 adenoid cystic carcinoma, salivary gland poorly differentiated carcinoma, high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, salivary gland malignant mixed cell type tumor, salivary gland adenocarcinoma, salivary gland anaplastic carcinoma, salivary gland squamous cell carcinoma