A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00337532

Purpose

The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Paclitaxel Drug: cisplatin	Phase II Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Paclitaxel Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.

Secondary Outcome Measures:

Toxicity for maximum 3 cycles

Estimated Enrollment:	50
Study Start Date:	May 2005
Study Completion Date:	June 2007

Arms	Assigned Interventions
paclitaxel-cisplatin combination regimen: Active Comparator	Drug: Paclitaxel Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days. Drug: cisplatin solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.

Arms

Assigned Interventions

paclitaxel-cisplatin combination regimen: Active Comparator

Drug: Paclitaxel

Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.

Drug: cisplatin

solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Locally advanced, Stage II-IV (except M1), hand and neck cancer
> = 1 measurable lesion
not been previously treated for head and neck cancer

Exclusion Criteria:

history of another malignancy
organ allografts
pre-exiting neuropathy > = CTC grade 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337532

Locations

Korea, Republic of
Local Institution
Seoul, Korea, Republic of
Local Institution
Seoul, Korea, Republic of
Local Insitution
Seoul, Korea, Republic of
Local Institution
Seoul, Korea, Republic of
Local Institution
Seoul, Korea, Republic of

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA139-384
Study First Received:	June 14, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00337532
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Cisplatin
Paclitaxel
Head and Neck Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009