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A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma of Unknown Primary, Head and Neck Cancer, Non-melanomatous Skin Cancer

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Trial Information

A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES:

- Determine the effect of SU5416 on survival and tumor response in patients with advanced
or recurrent squamous cell carcinoma of the head and neck.

- Determine the safety and toxicity of SU5416 in these patients.

OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the
absence of disease progression or unacceptable toxicity.

Patients are followed for 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1.4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven epidermoid/squamous cell carcinoma of the oral cavity, lip,
hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx; undifferentiated
carcinoma of the nasopharynx (WHO type III); sinonasal undifferentiated carcinoma; or
squamous cell carcinoma of unknown primary or the skin with initial presentation in
the head and neck region

- Advanced or recurrent disease that is incurable with surgery or radiotherapy

- No more than 2 prior cytotoxic chemotherapy regimens for recurrent, persistent, or
metastatic disease

- Prior exposure to chemopreventive agents (e.g., tretinoin or other vitamin
analogues) is not considered to be a prior cytotoxic chemotherapy exposure

- At least 1 measurable indicator lesion

- Bone metastases, elevated enzyme levels, or lesions on radionuclide scans are
not acceptable as the sole parameters of measurable disease

- No history of brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,000/mm3

- Hemoglobin greater than 8 g/dL

- Platelet count greater than 100,000/mm3

- No history of coagulation disorder

Hepatic:

- Bilirubin normal

- SGOT less than 2.5 times upper limit of normal

- PT no greater than 14 seconds

- aPTT no greater than 40 seconds

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No uncompensated coronary artery disease

- No myocardial infarction or severe/unstable angina within the past 6 months

- No severe peripheral vascular disease associated with diabetes mellitus

- No deep venous or arterial thrombosis within the past 3 months

- No unstable cardiac rhythm

- No cerebrovascular accident within the past 6 months

Pulmonary:

- No pulmonary embolism within the past 3 months

Other:

- No history of allergic reaction to paclitaxel

- No other active malignancy except:

- Basal cell or squamous cell skin cancer

- Carcinoma in situ of the cervix

- Synchronous epidermoid/squamous cell carcinoma of the head and neck (oral
cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active bacterial infection requiring antibiotics

- No other concurrent medical condition that would increase risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David G. Pfister, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068232

NCT ID:

NCT00006361

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Carcinoma of Unknown Primary
  • Head and Neck Cancer
  • Non-melanomatous Skin Cancer
  • squamous cell carcinoma of the skin
  • recurrent skin cancer
  • stage IV nasopharyngeal cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • squamous cell carcinoma of unknown primary
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent carcinoma of unknown primary
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasms, Unknown Primary

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021