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SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
This study has been completed.
First Received: November 9, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026260
  Purpose

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 II

Study Type: Interventional
Study Design: 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):

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026260

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Robert A. Burger, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069013, GOG-0227B
Study First Received: November 9, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00026260     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 25, 2009