Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced salivary gland cancer that cannot be removed during surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Gemcitabine for Advanced Salivary Cancer: A Phase II Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 1999 |
OBJECTIVES:
- Evaluate the response rate of patients with incurable salivary gland cancer treated with gemcitabine.
- Evaluate the time to progression and toxicity of this therapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV for 30 minutes on days 1, 8, and 15 of each 28 day course. Patients receive a minimum of 2 courses of treatment. Patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: This study will accrue a total of 16-60 patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically diagnosed metastatic salivary gland cancer including:
- Adenoid cystic carcinoma
- Mucoepidermoid carcinoma
- Acinic cell carcinoma
- Malignant mixed tumor
- Polymorphous low grade adenocarcinoma
- Undifferentiated carcinoma
- Squamous cell carcinoma
- Adenocarcinoma
- Local or distant metastases
- Unresectable tumor
- Unidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 2000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 8.5 g/dL OR
- Hematocrit greater than 25%
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- AST less than 2 times ULN (less than 5 times ULN if liver involved)
- Alkaline phosphatase less than 5 times ULN (no limit if liver involved)
Renal:
- Creatinine less than 1.5 times ULN OR
- Creatinine clearance at least 50% of lower limit of normal
Cardiovascular:
- No congestive heart failure
Pulmonary:
- No chronic obstructive pulmonary disease
Other:
At least 3 years since prior invasive neoplasm except:
- Nonmelanoma skin cancer
- Cervical cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other significant active illness (e.g., uncontrolled diabetes, AIDS)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 28 days since prior immunotherapy
- No concurrent immunotherapy
Chemotherapy:
- No prior cytotoxic chemotherapy for disease
- No other concurrent chemotherapy
Endocrine therapy:
- At least 28 days since prior hormone therapy
- No concurrent hormone therapy
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- At least 28 days since prior homeopathic, natural, or alternative therapies
- No concurrent homeopathic, natural, or alternative therapies
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Marshall R. Posner, MD | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003744 History of Changes |
| Other Study ID Numbers: | CDR0000066863, DFCI-98168, LILLY-DFCI-98168, NCI-G99-1496 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III salivary gland cancer stage IV salivary gland cancer salivary gland squamous cell carcinoma salivary gland acinic cell tumor low-grade salivary gland mucoepidermoid carcinoma high-grade salivary gland mucoepidermoid carcinoma |
salivary gland adenocarcinoma salivary gland poorly differentiated carcinoma salivary gland anaplastic carcinoma salivary gland malignant mixed cell type tumor salivary gland adenoid cystic carcinoma |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Salivary Gland Neoplasms Neoplasms by Site Neoplasms Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 18, 2013