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BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.

First Received on April 7, 2003.   Last Updated on July 23, 2008   History of Changes
Sponsor: University of Pennsylvania
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057850
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
 Drug: cisplatin
Drug: ixabepilone
 Phase I
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Cisplatin Ixabepilone
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057850

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
Investigators
Study Chair: Diane M. Hershock, MD, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00057850     History of Changes
Other Study ID Numbers: CDR0000276716, UPCC-04302, NCI-5787
Study First Received: April 7, 2003
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
 stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
stage IV salivary gland cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Neoplasms by Site
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012



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