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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
Not Enrolling
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

Performance status: ECOG performance status 0 or 1

Life expectancy: At least 3 months


- ANC of > 1,500/mm3

- Platelets > 100,000/mm3

- Hemoglobin > 8 gm/dl


- Total Bilirubin £ ULN

- Albumin > 3

- Maximum Alk Phos > 2.5 x < 5 x ULN


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


- 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.


- 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

- 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,

- 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:


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:


Principal Investigator

David Potter, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC


United States: Institutional Review Board

Study ID:

HOG HN02-40



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



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