Squamous Cell CarcinomaPhase 2NCT00400205

Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

A Phase 2 study testing Docetaxel, Cisplatin and 5-fluorouracil in people with Squamous Cell Carcinoma and Oral Cancer, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma, Oral Cancer
What is being tested?: Docetaxel, Cisplatin and 5-fluorouracil
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Aug 2006to Sep 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 proven squamous cell carcinoma of the oral cavity.
Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection.
Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in case of local symptoms.
At least one uni- or bi-dimensionally measurable lesion.
Age ≥ 18 years.
World Health Organization (WHO) performance status of 2 or less.
No active alcohol addiction.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Who cannot join

Pregnant or breast feeding
Previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
Patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
Concurrent treatment with any other anti-cancer therapy.
Participation in an investigational trial within 30 days of study entry.

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Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN [squamous cell carcinoma of the head and neck] (other than biopsy) are allowed at the time of study entry.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Winship Cancer Institute
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints

Read the detailed description

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.

Conditions: Squamous Cell Carcinoma, Oral Cancer
Being tested: Docetaxel, Cisplatin, 5-fluorouracil
Keywords: Squamous Cell Carcinoma of the Oral Cavity
Medical subject headings: Carcinoma, Squamous Cell, Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DocetaxelDrug
Also called Taxotere
Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
CisplatinDrug
Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
5-fluorouracilDrug
5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.

Study groups in NCT00400205
Study group	Role	What they receive
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil	Experimental	Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil. Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: 5-fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].
Measured: every 3 months

Secondary outcomes (1)

Tumor Change by Baseline Acetylated Tubulin Expression Score
Percent change in TNM stage of tumors after three cycles of study treatment was assessed to see if baseline acetylated tubulin (AT) expression predicts treatment success. Decreasing tumor stage change (a negative number) indicates that the tumor is responding to treatment while an increase means that the severity of the tumor is not decreasing. Immunohistochemistry (IHC) analysis of AT expression was performed in formalin-fixed, paraffin-embedded, pre-treatment tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining.
Data presented are adopted from Saba, NF, et. al. Acetylated Tubulin (AT) as a Prognostic Marker in Squamous Cell Carcinoma of the Head and Neck. Head and Neck Pathology (2014) 8:66-72.
Measured: Baseline, After 3 cycles of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Sep 2009

First posted16 Nov 2006 (estimated)
Study startAug 2006
Primary completionSep 2009
Study completionSep 2009

Why it stopped: Safety reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00400205
Sponsor's protocol ID: 0414-2006
Status last verified: Oct 2017
First submitted: 15 Nov 2006
Last updated: 6 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Saba NF, Magliocca KR, Kim S, Muller S, Chen Z, Owonikoko TK, Sarlis NJ, Eggers C, Phelan V, Grist WJ, Chen AY, Ramalingam SS, Chen ZG, Beitler JJ, Shin DM, Khuri FR, Marcus AI. Acetylated tubulin (AT) as a prognostic marker in squamous cell carcinoma of the head and neck. Head Neck Pathol. 2014 Mar;8(1):66-72. doi: 10.1007/s12105-013-0476-6. Epub 2013 Jul 24.
PubMed 23881549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints
ClinicalTrials.gov ID: NCT00400205
Acronym / sponsor ID: 0414-2006
Conditions: Squamous Cell Carcinoma, Oral Cancer
Keywords: Squamous Cell Carcinoma of the Oral Cavity
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Safety reasons
Enrolment: 14 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Sanofi
Study start: Aug 2006
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 16 Nov 2006 (estimated)
Results: Posted 4 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil	Experimental	Drug: Docetaxel, Drug: Cisplatin, Drug: 5-fluorouracilParticipants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Histologically or cytologically proven squamous cell carcinoma of the oral cavity.
Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection.
Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in case of local symptoms.
At least one uni- or bi-dimensionally measurable lesion.
Age ≥ 18 years.

Key exclusion criteria (9 listed)

Pregnant or breast feeding
Previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
Patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
Concurrent treatment with any other anti-cancer therapy.

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
DocetaxelAlso: TaxotereDocetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.	Drug	Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
CisplatinCisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.	Drug	Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
5-fluorouracil5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.	Drug	Recipients of Docetaxel, Cisplatin, 5-Fluorouracil

Primary outcome

Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
Time frame: every 3 months
Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].

1 secondary outcome

Tumor Change by Baseline Acetylated Tubulin Expression Score
Time frame: Baseline, After 3 cycles of study treatment

Results and safety

Results posted to the registry on 4 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil	14	9

Primary outcome: Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)

Time frame: every 3 months. Number. Unit: participants

Measure	Recipients of Docetaxel, Cisplatin, 5-Fluorouracil n = 9
Value	8

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil	6 of 14 (42.9%)	14 of 14 (100%)	3 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23881549Saba NF, Magliocca KR, Kim S, Muller S, Chen Z, Owonikoko TK, Sarlis NJ, Eggers C, Phelan V, Grist WJ, Chen AY, Ramalingam SS, Chen ZG, Beitler JJ, Shin DM, Khuri FR, Marcus AI. Acetylated tubulin (AT) as a prognostic marker in squamous cell carcinoma of the head and neck. Head Neck Pathol. 2014 Mar;8(1):66-72. doi: 10.1007/s12105-013-0476-6. Epub 2013 Jul 24.

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RecruitingObservational study
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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.

Nabil Saba, MD principal investigator

Emory University Winship Cancer Institute

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 Docetaxel, Cisplatin and 5-fluorouracil in people with Squamous Cell Carcinoma and Oral Cancer, run by Emory University 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 8 inclusion and 9 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 6 Nov 2017. 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?

Yes. Results are posted in the registry (first posted 4 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors) (time frame: every 3 months). 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 NCT00400205, which also lists 1 linked publication.

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 6 Nov 2017.