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Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Phase 2
18 Years
Not Enrolling
Neoplasms, Head and Neck Neoplasms

Thank you

Trial Information

Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2
given on day 1 by intravenous injection

Cycles are repeated every 21 days until disease progression, unacceptable toxicity or
subject's withdrawal.

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic or locoregionally recurrent
SCCHN deemed incurable by local therapy

- Measureable disease

- No prior use of palliative chemo after the SCCHN is deemed incurable by local therapy

- No prior treatment with oxaliplatin or docetaxel

- 18 years of age or older

- ECOG Performance status 0-1

- ANC 1,500/mcl or greater

- Adequate renal function

- Adequate liver function

- Recovered from acute and late effects of any prior treatment with a minimum of 4
weeks from the last session to enrollment in the study

- Patient or their legal representative must be able to read, understand, and provide
informed consent

- Patients of childbearing potential and their partners must agree to use an effective
form of contraception during the study and for 90 days following the last dose of
study medication

Exclusion Criteria:

- Patients with an active documented infection or with a fever (38.5 degrees celsius or
higher) within 3 days of the first scheduled dose of study treatment

- Patients with active CNS metastases

- Hypercalcemia related to SCCHN

- History of prior malignancy with the past 5 years except for curatively treated basal
cell carcinoma of the skin, cervical intraepithelial neoplasia or localized prostate

- Patients with known hypersensitivity to any of the components of oxaliplatin or
docetaxel or to other drugs formulated with polysorbate 90

- Patients receiving concurrent investigational therapy or investigational therapy less
than 30 days from first scheduled dose of study therapy

- Peripheral neuropathy grade 2 or higher

- Any medical condition deemed by the Investigator to be likely to interfere with a
patient's ability to sign informed consent, cooperate and participate in the study,
or interfere with the interpretation of the results

- History of allogeneic transplant

- Known HIV or Hepatitis B or C (active, previously treated or both)

Type of Study:


Study Design:

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

Outcome Measure:

Response rate as determined by RECIST criteria every 6 weeks.

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Balkrishna Jahagirdar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Minneapolis Veterans Affairs Medical Center


United States: Federal Government

Study ID:




Start Date:

April 2005

Completion Date:

November 2009

Related Keywords:

  • Neoplasms
  • Head and Neck Neoplasms
  • Recurrent Disease
  • Metastatic Disease
  • Squamous Cell Carcinoma
  • Multicenter
  • Phase II
  • Neoplasms
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



VA Medical CenterMinneapolis, Minnesota