NCT00005647

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 head-and-neck-cancer

Timeline
Completed

Started May 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

2.6 years

First QC Date

May 2, 2000

Last Update Submit

June 9, 2010

Conditions

Head and Neck Cancer

Keywords

thyroid gland medullary carcinomaanaplastic thyroid cancerrecurrent thyroid cancerrecurrent salivary gland cancerrecurrent metastatic squamous neck cancer with occult primarystage III follicular thyroid cancermetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent hypopharyngeal cancerstage III adenoid cystic carcinoma of the oral cavityrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent verrucous carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavityrecurrent squamous cell carcinoma of the oropharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.

    Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Interventions

paclitaxelDRUG

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

semaxanibDRUG

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

Also known as: SU5416

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, MedullaryThyroid Carcinoma, AnaplasticThyroid NeoplasmsSalivary Gland NeoplasmsAdenocarcinoma, FollicularHypopharyngeal NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, Olfactory

Interventions

PaclitaxelSemaxinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic DiseasesCarcinoma, Squamous CellNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Scot C. Remick, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

May 1, 2000

Primary Completion

December 1, 2002

Study Completion

October 1, 2003

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(1)