SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026260
First received: November 9, 2001
Last updated: June 20, 2013
Last verified: June 2007
  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 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:

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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00026260     History of Changes
Other Study ID Numbers: CDR0000069013, GOG-0227B
Study First Received: November 9, 2001
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 11, 2014