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SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
semaxanib
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, cervical squamous cell carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2001
    Last Updated
    June 20, 2013
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00026260
    Brief Title
    SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
    Official Title
    A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer
    Keywords
    recurrent cervical cancer, cervical squamous cell carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    semaxanib

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert A. Burger, MD
    Organizational Affiliation
    Chao Family Comprehensive Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

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