Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer
NCT ID: NCT00557206
Last Updated: 2013-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2005-04-30
2009-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
This is a single arm trial.
Oxaliplatin and Docetaxel
Chemotherapy
Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oxaliplatin and Docetaxel
Chemotherapy
Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Minneapolis Veterans Affairs Medical Center
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Balkrishna Jahagirdar
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Balkrishna Jahagirdar, MD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis Veterans Affairs Medical Center
Vicki A Morrison, MD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis Veterans Affairs Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Medical Center
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol. 2003 Aug;30(4 Suppl 15):5-13. doi: 10.1016/s0093-7754(03)00399-3.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VA-CORNET
Identifier Type: -
Identifier Source: secondary_id
OX-04-033
Identifier Type: -
Identifier Source: org_study_id