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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Diane M. Hershock, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02523

NCT ID:

NCT00057850

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283