SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

NCT00026260 | Completed Phase 2

• 2 other identifiers: CDR0000069013GOG-0227B
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer

Keywords

recurrent cervical cancer; cervical squamous cell carcinoma

Interventions

semaxanib DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Robert A. Burger, MD

  Chao Family Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: October 21, 2003
• Study Completion: October 1, 2003
• Last Updated: June 24, 2013

Record last verified: 2007-06