SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00026260
• Date of registration: 09/11/2001
• Primary sponsor: Gynecologic Oncology Group
• Public title: SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
• Scientific title: A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
• Date of first enrolment: November 2001
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00026260
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Contacts

• Name: Robert A. Burger, MD
• Affiliation: Chao Family Comprehensive Cancer Center

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Drug: semaxanib

Secondary ID(s)

CDR0000069013

GOG-0227B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)