Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00557206
• Other study ID #: OX-04-033
• Secondary ID: VA-CORNET
• Status: Terminated
• Phase: Phase 2
• First received: November 9, 2007
• Last updated: November 4, 2013
• Start date: April 2005
• Est. completion date: November 2009

Study information

• Verified date: November 2013
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Neoplasms

Intervention

Drug:
• Oxaliplatin and Docetaxel
Chemotherapy Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.

Locations

Country	Name	City	State
United States	VA Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Dieras V, Bougnoux P, Petit T, Chollet P, Beuzeboc P, Borel C, Husseini F, Goupil A, Kerbrat P, Misset JL, Bensmaïne 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. — View Citation

Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol. 2003 Aug;30(4 Suppl 15):5-13. Review. — View Citation

Ibrahim A, Hirschfeld S, Cohen MH, Griebel DJ, Williams GA, Pazdur R. FDA drug approval summaries: oxaliplatin. Oncologist. 2004;9(1):8-12. — View Citation

Kollmannsberger C, Rick O, Derigs HG, Schleucher N, Schöffski 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as determined by RECIST criteria every 6 weeks.		2 Years	No
Secondary	Toxicity and Quality of Life assessments every 3 weeks.		2 years	Yes