SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: semaxanib

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Robert A. Burger, MD, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: November 9, 2001
• First Submitted That Met QC Criteria: October 20, 2003
• First Posted (Estimate): October 21, 2003

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 20, 2013
• Last Verified: June 1, 2007

More Information

Terms related to this study

• Keywords: cervical squamous cell carcinoma; recurrent cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Semaxinib
• Other Study ID Numbers: CDR0000069013; GOG-0227B