Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase

Terminated

Phase 2

Conditions

Neoplasms

Head and Neck Neoplasms

Treatments

Drug: Oxaliplatin and Docetaxel

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

OX-04-033

VA-CORNET

Details and patient eligibility

About

Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.

Full description

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 cancer
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)