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 because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00101075
First received: January 7, 2005
Last updated: July 23, 2008
Last verified: November 2006
  Purpose

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment [ Designated as safety issue: No ]
  • Toxicity as assessed by CTCAE weekly [ Designated as safety issue: Yes ]
  • Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3 [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00101075

Locations
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
Investigators
Study Chair: Robert I. Haddad, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov 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
Health Authority: United States: Federal Government

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
Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Oxaliplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014