BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00057850
First received: April 7, 2003
Last updated: February 8, 2013
Last verified: April 2003
  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. 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.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: ixabepilone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
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:


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

Enrollment: 27
Study Start Date: January 2002
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

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.

Drug: cisplatin Drug: ixabepilone

Detailed Description:

OBJECTIVES:

I. 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) II. Determine the toxic effects of this regimen in these patients. III. Determine the response rate, time to progression, and survival of patients treated with this regimen. (Phase II) IV. Determine the pharmacokinetics of this regimen in these patients. V. 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.

  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

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:

Chemotherapy

  • No prior chemotherapy for recurrent disease

Radiotherapy

  • At least 6 months since prior radiotherapy and recovered

Surgery

  • Recovered from prior surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Diane M. Hershock, MD, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057850     History of Changes
Other Study ID Numbers: NCI-2012-02523, UPCC-04302, NCI-5787, CDR0000276716
Study First Received: April 7, 2003
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014