The goal of this clinical research study is to find out how effective oxaliplatin and
capecitabine are against advanced cancer of the salivary gland. The safety of this treatment
as well as how long the cancer responds or stays in a stable state due to the treatment will
also be studied.
This is a study of two investigational agents called oxaliplatin and capecitabine.
Investigational agents have not received Food and Drug Administration (FDA) approval for the
way they are being used in this study. This means an investigation drug is still under study
to determine what a safe dose is, what the side effects are and whether or not it is
effective in the disease or condition being studied.
Oxaliplatin and capecitabine are chemotherapy agents that have been approved by the FDA for
use in other cancers.
- Histologic diagnosis of any of the following malignancies originating from salivary
tissue: adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma,
malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated
carcinoma, squamous cell carcinoma, adenocarcinoma.
- Patients must be incurable on the basis of unresectable local or distant disease as
determined by the patient's surgeon and not be potentially curable by radiation
therapy as determined by a radiation oncologist.
- Patients may have received radiation to any site with the following caveat: the sites
used for evaluation for response are either not previously irradiated or they have
shown progression of disease post radiation and there has been a time interval of one
month since these sites were radiated.
- Patients must have an ECOG performance status of less than 3.
- Patients must have at least uni-dimensionally measurable disease documented within
one month of initiation of treatment. Measurement may be by physical exam or
radiologically. Attempts should be made to photo document all tumor sites assessed by
physical examination with a metric ruler within the photo for measurement
- Patients must be willing and able to go through the process of informed consent.
- Patients must have a life expectancy exceeding 3 months.
- Patients must be at least 18 years old.
- Patients must have adequate organ function as defined by the following tests to be
performed within 14 days of therapy initiation:
- Absolute neutrophil count > 1999 cells x 10 6/L
- Platelet count > 99,999 cells x 10 6/L
- Hemoglobin >8.5 gm/di or HCT > 25%
- Serum creatinine < 1.5 x institutional upper limits of normal (ULN) or
creatinine clearance measured by 24 hour urine collection as at least 50% of
institutional lower limit of normal.
- Total bilirubin <2 x institutional ULN
- AST (SGOT) <2 x institutional ULN*
- * If from documented liver involvement with cancer, may be up to < 5 x
institutional ULN Alkaline Phosphatase < 5 x institutional ULN #
- # If from documented bone or liver involvement with cancer, no upper limit
- Subjects (male or female) must agree to use effective methods of birth control while
- Subjects should be able to tolerate and swallow tablets or undergo GI tube insertion.
- Patients must have not received cytotoxic chemotherapy for metastatic salivary gland
cancer. Previous immunologic, hormonal, homeopathic, natural, or alternative medicine
therapies are acceptable provided treatment ended greater than 28 days prior to
protocol therapy. Patients may have received chemotherapy given concomitantly with
radiation therapy in an adjuvant setting with curative intent.
- Patients must not receive any form (including radiotherapeutic, immunologic,
hormonal,homeopathic, natural, or alternative medicine) of anti-neoplastic therapy
other than XELOX while participating in this study.
- Patients must not have a history of any invasive neoplasm within three years of trial
entry, excepting curatively treated non-melanoma skin cancer and cervical cancer.
- Pregnant and breast feeding women are not eligible for this study. No pregnancy test
is required. Women of childbearing potential must be counseled on the use of
effective birth control prior to participation in this study.
- Patients with significant active illness (e.g. congestive heart failure, COPD,
uncontrolled diabetes) are not eligible for this study.