Clinical trial NCT00101075: Title XELOX FOR SALIVARY GLAND CANCERS
Official title: Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Sanofi-Synthelabo
First posted: 2005-01-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

* 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 confirmation.
* 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 restriction.
* Subjects (male or female) must agree to use effective methods of birth control while on study.
* Subjects should be able to tolerate and swallow tablets or undergo GI tube insertion.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment
timeFrame: Every 2 Cycles
Secondary outcomes:
measure: Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment
timeFrame: Every 2 Cycles
measure: Toxicity as assessed by CTCAE weekly
timeFrame: Weekly
measure: Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3
timeFrame: Baseline andDay 3
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Robert I. Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References: