Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337532
First received: June 14, 2006
Last updated: February 2, 2010
Last verified: June 2008
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

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
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: paclitaxel-cisplatin combination regimen 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 Insitution
Seoul, Korea, Republic of
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional 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

No publications provided

ClinicalTrials.gov Identifier: NCT00337532     History of Changes
Other Study ID Numbers: CA139-384
Study First Received: June 14, 2006
Last Updated: February 2, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 21, 2013