SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00005647
First received: May 2, 2000
Last updated: June 9, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: paclitaxel Drug: semaxanib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Determine the maximum tolerated dose and safety of SU5416 and paclitaxel. [ Time Frame: Treatment continues weekly in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | May 2000 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: paclitaxel
Patients receive paclitaxel IV over one hour on day 1. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
Drug: 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.
Other Name: SU5416
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005647
Locations
| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Study Chair: | Scot C. Remick, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00005647 History of Changes |
| Other Study ID Numbers: | CWRU1399, U01CA062502, P30CA043703, CWRU-1399, NCI-T99-0084 |
| Study First Received: | May 2, 2000 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
thyroid gland medullary carcinoma anaplastic thyroid cancer recurrent thyroid cancer recurrent salivary gland cancer recurrent metastatic squamous neck cancer with occult primary stage III follicular thyroid cancer metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent hypopharyngeal cancer stage III adenoid cystic carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity |
recurrent adenoid cystic carcinoma of the oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent inverted papilloma of the paranasal sinus and nasal cavity recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Angiogenesis Inhibitors SU 5416 Paclitaxel Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
Growth Inhibitors Antineoplastic Agents Therapeutic Uses Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013