AzTrials
AzTrials

Cervical AdenocarcinomaPhase 2NCT00389974

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

A Phase 2 study testing sunitinib malate in people with Cervical Adenocarcinoma and Cervical Adenosquamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
sunitinib malate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteCanada
Study dates
Jan 2007to Mar 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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
  • 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
  • Bilirubin =< upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  • Calcium =< 3 mmol/L
  • Serum creatinine =< ULN or creatinine clearance >= 60ml/min if creatinine is > ULN; creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula
  • Patient consent must be obtained according to local institutional and/or University Human Experimentation Committee requirements; it will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) study coordinator that such clearance has been obtained, before the trial can commence in that center; because of differing requirements, a standard consent form for the trial will not be provided; a copy of the initial full board Research Ethics Board (REB) approval and approved consent form must be sent to the central office; the patient must sign the consent form prior to randomization or registration; please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records
  • Patients must be accessible for treatment, response assessment and follow-up; patients registered on this trial must be treated and followed at the participating center; this implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial; investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration; exceptions may be made however, regarding the washout period timing for prohibited medications

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • Patients with bowel obstruction or any condition (e.g. gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets
  • Patients with serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to:
  • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements
  • Active uncontrolled infection
  • Any other medical conditions that might be aggravated by treatment
  • Serious or non-healing wound, ulcer, or bone fracture
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
  • Use of agents with proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide) is not permitted during the study
  • Patients receiving azole antifungals (ketoconazole, itraconazole), clarithromycin, erythromycin, diltiazem, verapamil, human immunodeficiency virus (HIV) protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir) and delavirdine are not eligible unless >= 7 days since last dose before starting sunitinib and no dosing during the trial; patients receiving rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's wort, efavirenz and tipranavir are not eligible unless >= 12 days since last dose before starting sunitinib and no dosing during the trial
  • Patients with pre-existing hypothyroidism prior to enrollment are ineligible unless they are euthyroid on medication
  • Some women enrolled on this study will have had a prior hysterectomy for cervical cancer
  • Pregnant or lactating women; (N.B.: All women of childbearing potential must have a negative urine beta- human chorionic gonadotropin (beta-HCG) pregnancy test within 7 days prior to registration)
  • Women of childbearing potential who do not agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; (should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately)
  • Known HIV-positive patients on combination antiretroviral therapy are ineligible

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • National Cancer Institute of Canada Clinical Trials Group

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
sunitinib malate
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinib malateDrug

    Also called SU11248, sunitinib, Sutent

    Given PO

Study groups in NCT00389974
Study groupRoleWhat they receive
Treatment (sunitinib malate)ExperimentalPatients 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.
Receives: Drug: sunitinib malate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389974
Sponsor's protocol ID
NCI-2014-00648
Other IDs
NCI-2014-00648, NCIC CTG IND.184, IND.184, NCIC-184, NCIC-184
Status last verified
Mar 2014
First submitted
18 Oct 2006
Last updated
16 Feb 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate in people with Cervical Adenocarcinoma and Cervical Adenosquamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (PR or CR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389974.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in