Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery

NCT00389974 | Completed Phase 2 Results

• 4 other identifiers: NCI-2014-00648NCIC CTG IND.184IND.184NCIC-184
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Adenocarcinoma; Cervical Adenosquamous Cell Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Cancer; Stage IVB Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (PR or CR)

  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.

  Up to 2 years

Study Arms (1)

Treatment (sunitinib malate)

EXPERIMENTAL

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.

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Given PO

Also known as: SU11248, sunitinib, Sutent

Treatment (sunitinib malate)

Eligibility Criteria

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

You may qualify if:

• 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
• Patients may have had neoadjuvant or adjuvant chemotherapy
• Patients may have had concurrent chemoradiation; this is not considered neoadjuvant or adjuvant treatment
• Patients may have had no more than one prior chemotherapy regimen for recurrent metastatic disease; patients must be at least 28 days since last chemotherapy treatment and must have recovered from toxic effects
• Patients may have had prior radiation therapy, including external beam and/or intracavity radiation; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; patients must have recovered from any acute toxic effects from radiation prior to registration; radiation must have involved \< 30% of functioning bone marrow and there must be measurable disease outside the previously irradiated area (patients whose sole site of disease is in a previously irradiated area are ineligible UNLESS there is evidence of progression, or new lesions have been documented, in the irradiated field)
• Previous major surgery is permitted provided that it has been at least 28 days prior to patient registration and that wound healing has occurred
• Granulocytes (AGC) \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L

You may not qualify if:

• 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
• Poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher)
• Myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry
• History of pulmonary embolism within the past 12 months
• History of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
• Patients who require use of therapeutic doses of Coumadin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: low molecular weight heparin is permitted provided the patient's international normalized ratio (INR) is =\< 1.5; INR must be done within 7 days prior to registration

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute of Canada Clinical Trials Group

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Sunitinib

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Helen Mackay
• Organization: Princess Margaret Hospital, Toronto, Canada

helen.mackay@uhn.ca

(416) 946-2253

Study Officials

• Helen Mackay

  Canadian Cancer Trials Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 16, 2015
• Results First Posted: February 16, 2015

Record last verified: 2014-03

Locations

CA (1)