Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
OBJECTIVES:
Primary
- Determine the tumor response rate in patients with unresectable locally advanced or
metastatic incurable salivary gland cancer treated with capecitabine and oxaliplatin.
Secondary
- Determine time to disease progression in patients treated with this regimen.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours
on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease
progression or unacceptable toxicity. Patients achieving a positive response after 2 courses
receive additional courses of therapy in the absence of disease progression or unacceptable
toxicity. Patients achieving a complete response (CR) receive 2 additional courses of
treatment beyond CR.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed salivary gland cancer, including the following histologies:
- Adenoid cystic carcinoma
- Mucoepidermoid carcinoma
- Acinic cell carcinoma
- Malignant mixed tumor
- Polymorphous low-grade adenocarcinoma
- Undifferentiated carcinoma
- Squamous cell carcinoma
- Adenocarcinoma
- Incurable disease
- Unresectable local or distant disease
- At least 1 unidimensionally measurable lesion documented by physical exam or
radiology within the past month
- No prior radiotherapy to sites used for evaluation of response unless these
sites demonstrate disease progression after completion of radiotherapy
- Not amenable to potentially curative radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 8.5 g/dL
- Hematocrit > 25%
Hepatic
- Bilirubin < 2 times upper limit of normal (ULN)
- AST < 2 times ULN (5 times ULN with liver involvement)
- Alkaline phosphatase < 5 times ULN (no upper limit restriction with bone or liver
involvement)
Renal
- Creatinine < 1.5 times ULN OR
- Creatinine clearance ≥ 50% of lower limit of normal on 24-hour urine collection
Cardiovascular
- No congestive heart failure
Pulmonary
- No chronic obstructive pulmonary disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
participation
- Able to tolerate and swallow tablets OR undergo gastrointestinal tube insertion
- No uncontrolled diabetes
- No other significant active illness
- No other invasive malignancy within the past 3 years except curatively treated
nonmelanoma skin cancer or cervical cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 28 days since prior and no concurrent immunotherapy
Chemotherapy
- Prior adjuvant chemotherapy given with radiotherapy with curative intent allowed
- No prior cytotoxic chemotherapy for metastatic salivary gland cancer
Endocrine therapy
- More than 28 days since prior and no concurrent hormonal therapy
Radiotherapy
- See Disease Characteristics
- See Chemotherapy
- More than 1 month since prior radiotherapy to sites used for evaluation of response
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 28 days since prior and no concurrent homeopathic therapy
- More than 28 days since prior and no concurrent natural therapy
- More than 28 days since prior and no concurrent alternative medicine therapy
- No other concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
Safety Issue:
No
Principal Investigator
Robert I. Haddad, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000406025
NCT ID:
NCT00101075
Start Date:
October 2004
Completion Date:
Related Keywords:
- Head and Neck Cancer
- high-grade salivary gland mucoepidermoid carcinoma
- low-grade salivary gland mucoepidermoid carcinoma
- salivary gland acinic cell tumor
- salivary gland adenocarcinoma
- salivary gland adenoid cystic carcinoma
- salivary gland malignant mixed cell type tumor
- salivary gland poorly differentiated carcinoma
- salivary gland squamous cell carcinoma
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- Head and Neck Neoplasms
- Salivary Gland Neoplasms
Name | Location |
|---|---|
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
