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A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix


OBJECTIVES:

- Determine the antitumor cytostatic activity of SU5416, in terms of 6-month
progression-free survival and time to progression, in patients with persistent or
recurrent cervical squamous cell carcinoma.

- Determine the nature and degree of toxicity of this drug in these patients.

- Correlate surrogate endpoint molecular and imaging markers with clinical outcome in
patients treated with this drug.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 8-23
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed cervical squamous cell carcinoma

- Persistent or recurrent disease with documented progression

- No nonsquamous cell cervical malignancies, including adenosquamous carcinoma

- At least 1 measurable lesion

- At least 20 mm by conventional techniques, including palpation, plain x-ray, CT
scan, or MRI OR

- At least 10 mm by spiral CT scan

- Failed prior local therapeutic measures

- Ineligible for higher priority GOG protocol (e.g., any active GOG phase III protocol
for the same patient population)

- Tumor must be accessible for biopsy using direct- or guided-needle technique

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count at least lower limit of normal

- Absolute neutrophil count at least 1,500/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No uncompensated coronary artery disease on electrocardiogram or physical examination

- No myocardial infarction within the past 6 months

- No severe/unstable angina within the past 6 months

- No severe peripheral vascular disease

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

Pulmonary:

- No pulmonary embolism within the past 3 months

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Must have central venous access

- No uncontrolled diabetes mellitus

- No prior allergic reaction to paclitaxel

- No active infection requiring antibiotics

- No peripheral neuropathy greater than grade 1

- No contraindications to low-dose (1 mg/day) warfarin or low-molecular weight heparin
prophylaxis

- No claustrophobia that would preclude MRI studies

- No ferromagnetic implants or pacers

- No other invasive malignancy within the past 5 years except non-melanoma skin cancer

- No other concurrent circumstances that would preclude study completion

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Biologic therapy:

- No prior antiangiogenesis agents, including SU5416

- At least 3 weeks since prior biologic or immunologic agents directed at malignancy

Chemotherapy:

- No more than 1 prior chemotherapy regimen, including single or combination cytotoxic
drug therapy (radiosensitizers do not count as prior regimen)

- At least 3 weeks since prior chemotherapy directed at malignancy and recovered

Endocrine therapy:

- At least 1 week since prior hormonal therapy directed at malignancy

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- At least 3 weeks since prior radiotherapy directed at malignancy and recovered

Surgery:

- See Disease Characteristics

- At least 3 weeks since prior surgery for malignancy and recovered

Other:

- No prior cancer therapy that would preclude study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert A. Burger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069013

NCT ID:

NCT00026260

Start Date:

Completion Date:

October 2003

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

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