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Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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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 InstituteBoston, Massachusetts  02115