Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
NCT ID: NCT00400205
Last Updated: 2017-11-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
14 participants
INTERVENTIONAL
2006-08-31
2009-09-30
Brief Summary
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Detailed Description
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Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
Docetaxel
Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
Cisplatin
Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
5-fluorouracil
5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
Interventions
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Docetaxel
Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
Cisplatin
Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
5-fluorouracil
5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Emory University
OTHER
Responsible Party
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Nabil F. Saba
Professor
Principal Investigators
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Nabil Saba, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Winship Cancer Institute
Locations
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Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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References
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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.
Other Identifiers
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0414-2006
Identifier Type: -
Identifier Source: org_study_id