Clinical trial NCT00557206: Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer
Official title: Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neoplasms
Head and Neck Neoplasms
Keywords: Recurrent Disease
Metastatic Disease
Squamous Cell Carcinoma
Multicenter
Phase II
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Sanofi
First posted: 2007-11-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Response rate as determined by RECIST criteria every 6 weeks.
timeFrame: 2 Years
Secondary outcomes:
measure: Toxicity and Quality of Life assessments every 3 weeks.
timeFrame: 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Balkrishna Jahagirdar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Veterans Affairs Medical Center
name: Vicki A Morrison, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Degardin M, Cappelaere P, Krakowski I, Fargeot P, Cupissol D, Brienza S. Phase II trial of oxaliplatin (L-OHP) in advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck. Eur J Cancer B Oral Oncol. 1996 Jul;32B(4):278-9. doi: 10.1016/0964-1955(95)00082-8. No abstract available.
citation: Ibrahim A, Hirschfeld S, Cohen MH, Griebel DJ, Williams GA, Pazdur R. FDA drug approval summaries: oxaliplatin. Oncologist. 2004;9(1):8-12. doi: 10.1634/theoncologist.9-1-8.
citation: Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol. 2003 Aug;30(4 Suppl 15):5-13. doi: 10.1016/s0093-7754(03)00399-3.
citation: Rixe O, Ortuzar W, Alvarez M, Parker R, Reed E, Paull K, Fojo T. Oxaliplatin, tetraplatin, cisplatin, and carboplatin: spectrum of activity in drug-resistant cell lines and in the cell lines of the National Cancer Institute's Anticancer Drug Screen panel. Biochem Pharmacol. 1996 Dec 24;52(12):1855-65. doi: 10.1016/s0006-2952(97)81490-6.
citation: Kollmannsberger C, Rick O, Derigs HG, Schleucher N, Schoffski P, Beyer J, Schoch R, Sayer HG, Gerl A, Kuczyk M, Spott C, Kanz L, Bokemeyer C. Activity of oxaliplatin in patients with relapsed or cisplatin-refractory germ cell cancer: a study of the German Testicular Cancer Study Group. J Clin Oncol. 2002 Apr 15;20(8):2031-7. doi: 10.1200/JCO.2002.08.050.
citation: Dieras V, Bougnoux P, Petit T, Chollet P, Beuzeboc P, Borel C, Husseini F, Goupil A, Kerbrat P, Misset JL, Bensmaine MA, Tabah-Fisch I, Pouillart P. Multicentre phase II study of oxaliplatin as a single-agent in cisplatin/carboplatin +/- taxane-pretreated ovarian cancer patients. Ann Oncol. 2002 Feb;13(2):258-66. doi: 10.1093/annonc/mdf018.