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Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

Primary Purpose

Neoplasms, Head and Neck Neoplasms

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Oxaliplatin and Docetaxel

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Recurrent Disease, Metastatic Disease, Squamous Cell Carcinoma, Multicenter, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

This is a single arm trial.

Outcomes

Primary Outcome Measures

Response rate as determined by RECIST criteria every 6 weeks.

Secondary Outcome Measures

Toxicity and Quality of Life assessments every 3 weeks.

Full Information

NCT ID

NCT00557206

First Posted

November 9, 2007

Last Updated

November 4, 2013

Sponsor

Minneapolis Veterans Affairs Medical Center

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00557206

Brief Title

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

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Why Stopped

Funding was terminated

Study Start Date

April 2005 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minneapolis Veterans Affairs Medical Center

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Head and Neck Neoplasms

Keywords

Recurrent Disease, Metastatic Disease, Squamous Cell Carcinoma, Multicenter, Phase II

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

This is a single arm trial.

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin and Docetaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

Response rate as determined by RECIST criteria every 6 weeks.

Time Frame

2 Years

Secondary Outcome Measure Information:

Title

Toxicity and Quality of Life assessments every 3 weeks.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Balkrishna Jahagirdar, MD

Organizational Affiliation

Minneapolis Veterans Affairs Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vicki A Morrison, MD

Organizational Affiliation

Minneapolis Veterans Affairs Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Medical Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8776427

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.

Results Reference

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PubMed Identifier

14755010

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.

Results Reference

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PubMed Identifier

14523789

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.

Results Reference

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PubMed Identifier

8951344

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.

Results Reference

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PubMed Identifier

11956262

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.

Results Reference

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PubMed Identifier

11886003

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.

Results Reference

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Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

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