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Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Salivary Gland Cancer That Cannot Be Removed By Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: January 7, 2005
Last updated: July 23, 2008
Last verified: November 2006

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine together with oxaliplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced or metastatic salivary gland cancer that cannot be removed by surgery.

Condition Intervention Phase
Head and Neck Cancer
Drug: capecitabine
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment

Secondary Outcome Measures:
  • Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment
  • Toxicity as assessed by CTCAE weekly
  • Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3

Estimated Enrollment: 33
Study Start Date: October 2004
Detailed Description:



  • Determine the tumor response rate in patients with unresectable locally advanced or metastatic incurable salivary gland cancer treated with capecitabine and oxaliplatin.


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 8.5 g/dL
  • Hematocrit > 25%


  • 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)


  • Creatinine < 1.5 times ULN OR
  • Creatinine clearance ≥ 50% of lower limit of normal on 24-hour urine collection


  • No congestive heart failure


  • No chronic obstructive pulmonary disease


  • 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


Biologic therapy

  • More than 28 days since prior and no concurrent immunotherapy


  • 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


  • See Disease Characteristics
  • See Chemotherapy
  • More than 1 month since prior radiotherapy to sites used for evaluation of response
  • No concurrent radiotherapy


  • Not specified


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00101075

United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Robert I. Haddad, MD Dana-Farber Cancer Institute
  More Information Identifier: NCT00101075     History of Changes
Other Study ID Numbers: CDR0000406025  DFCI-04149  SANOFI-DFCI-04149 
Study First Received: January 7, 2005
Last Updated: July 23, 2008

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Salivary Gland Neoplasms
Neoplasms by Site
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on February 24, 2017