SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00026260
Recruitment Status : Completed
First Posted : October 21, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

November 9, 2001
October 21, 2003
June 24, 2013
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Complete list of historical versions of study NCT00026260 on Archive Site
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SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.


  • 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.

Phase 2
Primary Purpose: Treatment
Cervical Cancer
Drug: semaxanib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2003
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  • 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



  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


  • Platelet count at least lower limit of normal
  • Absolute neutrophil count at least 1,500/mm^3


  • 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


  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance greater than 60 mL/min


  • 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


  • No pulmonary embolism within the past 3 months


  • 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


  • See Disease Characteristics

Biologic therapy:

  • No prior antiangiogenesis agents, including SU5416
  • At least 3 weeks since prior biologic or immunologic agents directed at malignancy


  • 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


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


  • See Disease Characteristics
  • At least 3 weeks since prior surgery for malignancy and recovered


  • No prior cancer therapy that would preclude study
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert A. Burger, MD Chao Family Comprehensive Cancer Center
National Cancer Institute (NCI)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP