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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response measured by RECIST criteria after accrual of 11 evaluable patients

Safety Issue:

No

Principal Investigator

Lillian L. Siu, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

HN4

NCT ID:

NCT00079079

Start Date:

October 2003

Completion Date:

February 2009

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms
  • Salivary Gland Neoplasms

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