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A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40


OUTLINE: This is a multi-center study.

- Dexamethasone and antiemetic premedication1.

- Docetaxel: 60 mg/m2 for a 60 minute infusion day 1 of each cycle

- Capecitabine: 825 mg/m2 po BID Days 1-14

Repeat every 21 days until tumor progression or toxicity that requires discontinuation of
therapy

Performance status: ECOG performance status 0 or 1

Life expectancy: At least 3 months

Hematopoietic:

- ANC of > 1,500/mm3

- Platelets > 100,000/mm3

- Hemoglobin > 8 gm/dl

Hepatic:

- Total Bilirubin £ ULN

- Albumin > 3

- Maximum Alk Phos > 2.5 x < 5 x ULN

Renal:

- Creatinine clearance of > 50 ml/ min (by Cockcroft-Gault)

Cardiovascular:

- No decompensated congestive heart failure or active angina.

- Clinically significant cardiac disease not well controlled with medication (eg.
congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias)
or myocardial infarction in the past 12 months is not allowed.

Pulmonary:

- Not specified


Inclusion Criteria:



- Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head
and neck.

- Recurrent/metastatic disease not amenable to surgery or salvage chemoradiation.

- Unidimensional measurable disease according to the RECIST

- In-field recurrence, within a prior radiation field only, distant metastatic disease

- Both in-field and metastatic sites of disease will require evaluation by a Radiation
Oncologist to consider local radiation therapy first and will be eligible for
possible enrollment one month after completion of the radiation therapy.

- Negative pregnancy test

- Patients may have received prior chemotherapy as part of chemoradiation or induction
chemotherapy for initial treatment of disease confined to the head and neck region -
Patients must have fully recovered from any prior radiation therapy

Exclusion Criteria:

- Patients who have relapsed < 6 months after completing a combined modality curative
treatment that included a fluoropyrimidine or taxanes

- No brain metastases

- No major neurological disease, including stroke

- No prior chemotherapy regimen for recurrent/metastatic disease

- No prior history of capecitabine usage

- No prior history of docetaxel usage except in the induction setting for head and neck
cancer which has been completed for greater than 6 months prior to beginning protocol
therapy

- No past hypersensitivity to taxanes or 5 FU

- No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

- No current use of warfarin

- Patients must not be receiving ketoconazole, midazolam, erythromycin, orphenadrine,
troleandomycin, cyclosporine or antiepileptics

- Patients must not be treated with any of the following on protocol therapy or within
28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine,
allopurinol

- Patients must have fully recovered from any prior surgery

- No known HIV seropositivity.

- No serious uncontrolled medical condition, uncontrolled peptic ulcer disease or
malabsorption syndrome

- No peripheral neuropathy > grade 1

- Patients with a percutaneous gastrostomy (PEG) must be able take medications by tube.

- No daily consumption of alcohol

- No active infection

- No prior history of malignancy in the last 5 years, excluding in situ carcinoma of
the cervix or adequately treated basal or squamous cell carcinoma of the skin or
Gleason Grade < VII organ confined prostate cancer.

- No current breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

- To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

David Potter, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC

Authority:

United States: Institutional Review Board

Study ID:

HOG HN02-40

NCT ID:

NCT00216138

Start Date:

March 2004

Completion Date:

September 2007

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Siteman Cancer Center Saint Louis, Missouri  63110
Center for Cancer Care at Goshen Health System Goshen, Indiana  46526
Helen F. Graham Cancer Center Newark, Delaware  19713
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Chicago Chicago, Illinois  60637
Methodist Cancer Center Omaha, Nebraska  68114
Arnett Cancer Care Lafayette, Indiana  47904
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Oncology Hematology Associates of SW Indiana Evansville, Indiana  47714
Providence Medical Group Terre Haute, Indiana  47802
Elkhart Clinic Elkhart, Indiana  46515
Quality Cancer Center (MCGOP) Indianapolis, Indiana  46202
Medical Consultants, P.C. Muncie, Indiana  47303
Center for Cancer Care, Inc., P.C. New Albany, Indiana  47150
AP&S Clinic Terre Haute, Indiana  47804
Fort Wayne Oncology & Hematology, Inc Fort Wayne, Indiana  46815
Center for Hematology-Oncology of S Michigan Jackson, Michigan  49201