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A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma


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

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Trial Information

A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma


OBJECTIVES:

Primary

- Determine the overall response rate (complete response and partial response) in
patients with previously treated recurrent locoregional or metastatic carcinoma of the
nasopharynx treated with capecitabine.

Secondary

- Determine median progression-free survival of patients treated with this drug.

- Determine median overall survival of patients treated with this drug.

- Correlate tissue thymidine phosphorylase (TP) levels with response to this drug in
these patients.

- Correlate the Epstein-Barr virus (EBV) status of these patients with response to this
drug.

- Correlate survival with the EBV status of patients treated with this drug.

- Correlate TP levels with EBV status of patients treated with this drug.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21
days.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed carcinoma of the nasopharynx

- WHO type I, II, or III

- Recurrent locoregional or metastatic disease

- The following primary tumor sites or types are excluded:

- Nasal cavity

- Paranasal sinus

- Sinonasal neuroendocrine carcinoma

- Primary malignancy of the salivary gland

- Received at least 1, but no more than 2, prior chemotherapy regimens for recurrent
locoregional or metastatic disease

- Patients who are intolerant of OR have a condition that precludes platinum-based
chemotherapy are eligible

- Available tumor tissue

- Measurable disease

- At least 1 lesion that has not been irradiated within the past 6 months

- More than 10 mm by spiral CT scan (20 mm by conventional techniques)

- Pleural effusion or bone metastases are not considered measurable disease

- No CNS metastases unless stable for > 3 months

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- More than 3 months

Hematopoietic

- Neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN (5 times ULN if due to liver metastases)

- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if due to liver metastases; 10
times ULN if due to bone metastases)

Renal

- Creatinine clearance ≥ 30 mL/min OR

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No congestive heart failure

- No symptomatic coronary artery disease

- No cardiac arrhythmias not well controlled by medication

- No myocardial infarction within the past year

- No other clinically significant cardiac disease

Neurologic

- No history of uncontrolled seizures

- No clinically significant CNS disorder or psychiatric disability that would preclude
giving informed consent or complying with study treatment

Immunologic

- No prior unanticipated severe reaction to fluoropyrimidines

- No extreme sensitivity to fluorouracil

- No serious, uncontrolled infection

Other

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No malabsorption syndrome of the upper gastrointestinal tract

- No other serious uncontrolled medical condition that would preclude study
participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- More than 6 months since prior fluoropyrimidines, including fluorouracil

- More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

Surgery

- More than 4 weeks since prior major surgery and recovered

Other

- More than 4 weeks since prior investigational drugs

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response as assessed by RECIST criteria

Safety Issue:

No

Principal Investigator

Lori J. Wirth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000393550

NCT ID:

NCT00095901

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage II squamous cell carcinoma of the nasopharynx
  • Head and Neck Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115