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Phase I Trial of Induction Paraplatin® and Xeloda® Followed by Concurrent Paraplatin and Xeloda With Intensity Modulated Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase I Trial of Induction Paraplatin® and Xeloda® Followed by Concurrent Paraplatin and Xeloda With Intensity Modulated Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES:

Primary

- Determine the maximum tolerated dose (MTD) of capecitabine when administered with
carboplatin as induction chemotherapy in patients with stage III-IVB squamous cell
carcinoma of the head and neck.

- Determine the MTD of capecitabine when administered with concurrent carboplatin and
intensity-modulated radiotherapy in these patients.

- Determine the toxicity of this regimen in these patients.

Secondary

- Determine, preliminarily, tumor response in patients treated with this regimen.

- Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of capecitabine.

- Induction chemotherapy: Patients receive carboplatin IV on days 1, 8, 15, 22, 29, and
36 and oral capecitabine twice daily on days 1-14 and 22-35.

- Concurrent chemoradiotherapy: Beginning 2 weeks after completion of induction
chemotherapy, patients receive carboplatin and capecitabine as in induction
chemotherapy. Patients also undergo intensity-modulated radiotherapy (IMRT) once daily
on days 1-5, 8-12, 15-19, 22-26, and 29-33 and non-IMRT boost once daily on days 36-40
and 43-47.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Within 4-8 weeks after completion of concurrent chemoradiotherapy, patients who achieve a
clinical complete response or who are medically operable with resectable persistent or
recurrent disease undergo neck dissection (salvage surgery).

Cohorts of 3-6 patients receive escalating doses of capecitabine (during both induction
chemotherapy and concurrent chemoradiotherapy) until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that which 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity.

Quality of life is assessed at baseline, after completion of induction chemotherapy, and
then at 1 week and 3, 6, and 12 months after completion of concurrent chemoradiotherapy.

After completion of study therapy, patients are followed monthly for 3 months and then every
3 months for 1 year.

PROJECTED ACCRUAL: Approximately 6-48 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of
the following types:

- Oral cavity

- Oropharynx

- Hypopharynx

- Clinical stage III-IVB (T2-T4, N0-N3, M0) disease

- Measurable disease by physical exam, endoscopy, and/or CT scan or MRI

- Residual measurable disease after fine needle aspiration, core needle biopsy, or
incisional or excisional biopsy of the primary tumor

- No evidence of distant metastases (M1)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 9 g/dL

- No uncontrolled coagulopathy

Hepatic

- AST < 2 times normal

- Alkaline phosphatase < 2 times normal

- Bilirubin normal

Renal

- Creatinine < 2.0 mg/dL OR

- Creatinine clearance > 50 mL/min

Cardiovascular

- No congestive heart failure

- No symptomatic coronary artery disease

- No uncontrolled cardiac arrhythmias

- No myocardial infarction within the past year

- No other clinically significant cardiac disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 30 days
after completion of study treatment

- Nutritional and general physical condition must be compatible with proposed study
treatment

- Mentally reliable

- No pre-existing peripheral neuropathy > grade 1

- No history of hypersensitivity to fluorouracil, capecitabine, or carboplatin

- No active infection

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- No major medical, psychiatric, or neurologic illness that would preclude study
participation or giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 5 years since prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for head and neck tumor

- No prior radiotherapy to the region of planned study radiotherapy fields

Surgery

- Recovered from prior surgery

- No unhealed surgical wounds

Other

- More than 4 weeks since prior investigational drugs

- No concurrent warfarin, diphenylhydantoin, or fluconazole unless willing to undergo
careful monitoring and appropriate dose adjustments

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Christopher Y. Thomas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000432949

NCT ID:

NCT00114153

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Virginia Cancer Center at UV Health SystemCharlottesville, Virginia  22908