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BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
Study NCT00057850   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2003   Last Updated: July 23, 2008   History of Changes

April 7, 2003
July 23, 2008
January 2002
 
 
 
Complete list of historical versions of study NCT00057850 on ClinicalTrials.gov Archive Site
 
 
 
BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Phase I/II Trial of the Epothilone B Analogue BMS 247550 (NSC 710428)/Cisplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining BMS-247550 with cisplatin in treating patients who have metastatic or recurrent head and neck cancer.

OBJECTIVES:

  • Determine the recommended phase II dose of BMS-247550 when administered with cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. (Phase I)
  • Determine the toxic effects of this regimen in these patients.
  • Determine the response rate, time to progression, and survival of patients treated with this regimen. (Phase II)
  • Determine the pharmacokinetics of this regimen in these patients.
  • Correlate selected markers from peripheral blood mononuclear cells and tumor samples with toxicity and response in patients treated with this regimen.

OUTLINE: This is an open-label, dose-escalation study of BMS-247550.

  • Phase I: Patients receive BMS-247550 IV over 3 hours and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 additional patients receive treatment as above at the recommended phase II dose of BMS-247550.

  • Phase II: Patients receive treatment as in Phase I at the recommended phase II dose of BMS-247550.

PROJECTED ACCRUAL: Approximately 3-47 patients (20-27 for phase II) will be accrued for this study within 1 year.

Phase I, Phase II
Interventional
Treatment, Open Label
Head and Neck Cancer
  • Drug: cisplatin
  • Drug: ixabepilone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck considered incurable by surgery or radiotherapy

    • No nasopharyngeal disease as primary site
  • Extensive, local-regional or distant metastatic disease

    • Newly diagnosed OR
    • Recurrent disease after initial treatment with surgery or radiotherapy (including neoadjuvant chemotherapy or concurrent chemoradiotherapy)
  • Measurable disease

    • If only site of measurable disease is in a previously irradiated area, disease progression after radiotherapy must be documented

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • Transaminases no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver involvement)

Renal

  • Creatinine no greater than 1.5 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of active infection
  • No other malignancy within the past 2 years except curatively treated stage 0 or I cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy for recurrent disease

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057850
 
CDR0000276716, UPCC-04302, NCI-5787
University of Pennsylvania
National Cancer Institute (NCI)
Study Chair: Diane M. Hershock, MD, PhD Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP