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SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 21, 2003
Last Update Posted: June 24, 2013
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.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition Intervention Phase
Cervical Cancer Drug: semaxanib Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Completion Date: October 2003
Detailed Description:


  • 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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026260

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert A. Burger, MD Chao Family Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00026260     History of Changes
Other Study ID Numbers: CDR0000069013
First Submitted: November 9, 2001
First Posted: October 21, 2003
Last Update Posted: June 24, 2013
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action