A Phase II Study of Sunitinib (SU11248; NSC 736511) an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Unresectable, Locally Advanced or Metastatic Cervical Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- sunitinib malate
- Conditions
- Cervical Adenocarcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (PR or CR)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the efficacy (objective response rate) of sunitinib (sunitinib malate) given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. II. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. III. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration. OUTLINE: Patients receive sunitinib malate orally (PO) daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) may receive 2 courses after CR or PR is reached. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix; patients with adenocarcinoma of the cervix will also be included since, although infrequent, their management in general is similar to those with squamous tumors
- •Patients must have advanced (stage IVB) recurrent or persistent disease unsuitable for curative treatment by surgery and/or radiation therapy
- •Presence of clinically and/or radiologically documented disease; at least one site of disease must be unidimensionally measurable as follows:
- •X-ray, physical exam \>= 20 mm
- •Spiral computed tomography (CT) scan \>= 10 mm
- •Non-spiral CT scan \>= 20 mm
- •All radiology studies must be performed within 21 days prior to registration (within 28 days if negative)
- •Patients must have a life expectancy of at least 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; performance status (PS) 2 patients are eligible if, in the opinion of the investigator, they are suitable for inclusion in the study and are likely to be compliant with the study procedures (in particular the recommendations for supportive care and dose modifications)
- •Patients may have had neoadjuvant or adjuvant chemotherapy
Exclusion Criteria
- •History of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for \>= 5 years
- •Patients with known brain metastases; (a head CT is not necessary to rule out brain metastases, unless there is clinical suspicion of central nervous system \[CNS\] involvement); patients with known brain metastases will be excluded from this trial due to their poor prognosis and their likelihood of developing progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
- •Patients receiving concurrent treatment with other anti-cancer therapy or other investigational anticancer agents
- •Patients who have received prior treatment with any other antiangiogenic agent or multi-targeted tyrosine kinase inhibitors (e.g., bevacizumab, sorafenib, pazopanib, thalidomide, AZD2171, AZD6474, AMG-706, PTK787, vascular endothelial growth factor \[VEGF\] Trap, etc.) are ineligible
- •Corrected QT (QTc) prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant electrocardiogram (ECG) abnormalities; an ECG must be done within 14 days prior to registration
- •Current or history of class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- •Patients with prior anthracycline exposure, previous central thoracic radiation that included heart in radiation port, or a history of NYHA Class II cardiac function UNLESS
- •They are currently asymptomatic with respect to cardiac function AND
- •Left ventricular ejection fraction (LVEF) as assessed by multi gated acquisition (MUGA) at baseline is \> lower limit of normal (LLN) of institution; the MUGA must be done within 14 days prior to registration
Arms & Interventions
Treatment (sunitinib malate)
Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
Intervention: sunitinib malate
Outcomes
Primary Outcomes
Objective Response Rate (PR or CR)
Time Frame: Up to 2 years
It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.