SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026260
• Other study ID #: CDR0000069013
• Secondary ID: GOG-0227B
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2001
• Last updated: June 20, 2013
• Est. completion date: October 2003

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• semaxanib

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)