NeoplasmsPhase 2NCT00557206
Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer
A Phase 2 study testing Oxaliplatin and Docetaxel in people with Neoplasms and Head and Neck Neoplasms, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Head and Neck Neoplasms
- What is being tested?
- Oxaliplatin and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.
Read the 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.
- Conditions
- Neoplasms, Head and Neck Neoplasms
- Being tested
- Oxaliplatin and Docetaxel
- Keywords
- Recurrent Disease, Metastatic Disease, Squamous Cell Carcinoma, Multicenter, Phase II
- Medical subject headings
- Neoplasms, Head and Neck Neoplasms, Recurrence, Neoplasm Metastasis, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin and DocetaxelDrug
Chemotherapy
Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This is a single arm trial. Receives: Drug: Oxaliplatin and Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate as determined by RECIST criteria every 6 weeks.
Measured: 2 Years
Secondary outcomes (1)
Toxicity and Quality of Life assessments every 3 weeks.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startApr 2005
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Funding was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Balkrishna Jahagirdar, Minneapolis Veterans Affairs Medical Center
- Investigators
- Balkrishna Jahagirdar, MD, Principal investigator, Minneapolis Veterans Affairs Medical CenterVicki A Morrison, MD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557206
- Sponsor's protocol ID
- OX-04-033
- Other IDs
- VA-CORNET
- Status last verified
- Nov 2013
- First submitted
- 9 Nov 2007
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8776427Ibrahim 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.
PubMed 14755010Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol. 2003 Aug;30(4 Suppl 15):5-13. doi: 10.1016/s0093-7754(03)00399-3.
PubMed 14523789Rixe 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.
PubMed 8951344Kollmannsberger 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.
PubMed 11956262Dieras 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.
PubMed 11886003
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
- ClinicalTrials.gov ID
- NCT00557206
- Acronym / sponsor ID
- OX-04-033
- Conditions
- Neoplasms, Head and Neck Neoplasms
- Keywords
- Recurrent Disease, Metastatic Disease, Squamous Cell Carcinoma, Multicenter, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was terminated
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Sanofi
- Study start
- Apr 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxaliplatin and DocetaxelThis is a single arm trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxaliplatin and DocetaxelChemotherapy Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days. | Drug | 1 |
Primary outcome
Response rate as determined by RECIST criteria every 6 weeks.
Time frame: 2 Years
1 secondary outcome
Toxicity and Quality of Life assessments every 3 weeks.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Funding was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
- Background: PubMed 8776427Degardin 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.
- Background: PubMed 14755010Ibrahim 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.
- Background: PubMed 14523789Grothey A. Oxaliplatin-safety profile: neurotoxicity. Semin Oncol. 2003 Aug;30(4 Suppl 15):5-13. doi: 10.1016/s0093-7754(03)00399-3.
- Background: PubMed 8951344Rixe 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.
- Background: PubMed 11956262Kollmannsberger 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.
- Background: PubMed 11886003Dieras 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balkrishna Jahagirdar, MD principal investigator
Minneapolis Veterans Affairs Medical Center
Vicki A Morrison, MD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin and Docetaxel in people with Neoplasms and Head and Neck Neoplasms, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate as determined by RECIST criteria every 6 weeks. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00557206, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.