SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck

Head and Neck Cancer Clinical Trial

Official title:

A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Paclitaxel in Recurrent or Metastatic Carcinoma of the Head and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005647
• Other study ID #: CWRU1399
• Secondary ID: U01CA062502P30CA
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2000
• Last updated: June 9, 2010
• Start date: May 2000
• Est. completion date: October 2003

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients with recurrent or metastatic head and neck cancer.

• Determine the antiangiogenesis effect of this combination regimen in these patients.

• Determine the toxicity, pharmacodynamic effects, and pharmacokinetic parameters of this combination.

OUTLINE: This is a dose escalation study.

Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study within 9-15 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Metastatic or loco-regionally recurrent malignancy of the head and neck (including salivary gland and thyroid) that is incurable by surgery or radiotherapy

• At least two distinct tumor masses OR

• One tumor mass at least 3 cm in diameter

• No brain metastases

• No pulmonary metastases as only site of disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,500/mm3

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin greater than 9.0 g/dL

Hepatic:

• PT and PTT normal OR

• INR ratio less than 1.1

• Bilirubin less than 1.5 mg/dL

• AST and ALT less than 2 times upper limit of normal

Renal:

• Creatinine less than 1.5 mg/dL

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• No uncompensated coronary artery disease

• No history of myocardial infarction or severe or unstable angina within the past 6 months

• No severe peripheral vascular disease

• No deep venous thrombosis or arterial thrombosis within the past 6 months

• No known hypercoagulable syndrome with predisposition to venous or arterial clots

Pulmonary:

• No pulmonary embolism within the past 6 months

Other:

• No prior cerebral hemorrhage

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since palliative chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

• At least 4 weeks since combined chemoradiotherapy and recovered

• Must be recovered from prior taxanes

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior large field radiotherapy and recovered

Surgery:

• Not specified

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• paclitaxel
Patients receive paclitaxel IV over one hour on day 1. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
• semaxanib
Patients receive SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.		Treatment continues weekly in the absence of disease progression or unacceptable toxicity.	Yes