Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
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ClinicalTrials.gov Identifier: NCT00079079 |
Recruitment Status :
Completed
First Posted : March 9, 2004
Last Update Posted : April 6, 2020
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Cisplatin and Gemcitabine in Patients With Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumors |
Actual Study Start Date : | October 23, 2003 |
Actual Primary Completion Date : | September 29, 2008 |
Actual Study Completion Date : | February 10, 2009 |

- Objective response measured by RECIST criteria after accrual of 11 evaluable patients
- Toxicity assessed by NCI CTC v2.0
- Overall survival

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079079
Canada, Manitoba | |
CancerCare Manitoba | |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Canada, Ontario | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Ottawa Hospital Regional Cancer Centre - General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada |
Responsible Party: | NCIC Clinical Trials Group |
ClinicalTrials.gov Identifier: | NCT00079079 |
Other Study ID Numbers: |
HN4 CAN-NCIC-HN4 ( Other Identifier: PDQ ) LILLY-CAN-NCIC-HN4 ( Other Identifier: LILLY ) CDR0000353487 ( Other Identifier: PDQ ) |
First Posted: | March 9, 2004 Key Record Dates |
Last Update Posted: | April 6, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 malignant mixed cell type 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 adenocarcinoma salivary gland anaplastic carcinoma salivary gland squamous cell carcinoma |
Salivary Gland Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Gemcitabine Cisplatin Carboplatin |
Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |