Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

Phase 2

Terminated

• Conditions: Neoplasms; Head and Neck Neoplasms
• Interventions: Drug: Oxaliplatin and Docetaxel

• Registration Number: NCT00557206
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Oxaliplatin and Docetaxel	This is a single arm trial.

Primary Outcome Measures

Name	Time	Method
Response rate as determined by RECIST criteria every 6 weeks.	2 Years

Secondary Outcome Measures

Name	Time	Method
Toxicity and Quality of Life assessments every 3 weeks.	2 years

Trial Locations

Locations (1)

VA Medical Center; 🇺🇸 Minneapolis, Minnesota, United States