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Recurrent Fallopian Tube CancerPhase 2NCT00388037

Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 2 study testing sunitinib malate and laboratory biomarker analysis in people with Recurrent Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, 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
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Trial summary

This phase II trial studies the side effects and how well sunitinib malate works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they need to grow. It may also shrink tumors. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
sunitinib malate and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteCanada
Study dates
Jan 2007to Jan 2012
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 confirmed epithelial ovarian, primary fallopian or primary peritoneal cancer
  • Patients must have advanced and/or metastatic disease, incurable by standard therapies
  • Patients must have received one or two prior chemotherapy regimens (one must have been platinum containing) and may be either platinum sensitive or platinum resistant
  • Nota bene (NB): For the purposes of this trial, switching from one platinum compound to another for reasons of disease progression or failure to respond will be considered a second regimen; as well, the same regimen given as first and second-line therapy is also considered two regimens
  • 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
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  • Spiral computed tomography (CT) scan >= 10 mm; N.B.: Most Canadian hospitals have spiral CT scanning equipment
  • Non-spiral CT scan >= 20 mm; N.B.: Most Canadian hospitals have spiral CT scanning equipment
  • All radiology studies must be performed within 21 days prior to registration (within 28 days if negative)
  • Patients with CA125 as only evidence of disease are not eligible
  • Patients must have a life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Hormonal therapy: Patients may have had up to one prior hormonal treatment for metastatic disease; patients must be at least 28 days since last dose of hormonal therapy
  • Chemotherapy: Patients must have had a minimum of one and up to two prior chemotherapy regimens, one of which must have contained a platinum agent; patients must be at least 28 days since last chemotherapy treatment and must have recovered from toxic effects
  • Radiation: Patients may have had prior radiation therapy; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; 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); (exceptions may be made however, for low dose, palliative radiotherapy); patients must have recovered from any acute toxic effects from radiation prior to registration
  • Previous surgery: 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 (absolute granulocyte count [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 >= 60 ml/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; 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, curatively treated in-situ cancer of the cervix, 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
  • 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, AZD6474, AMG-706, AZD2171, PTK787, vascular endothelial growth factor [VEGF] Trap, etc.) are ineligible
  • Patients with any of the following cardiovascular findings are to be excluded:
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  • Corrected QT interval (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 scan (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 coumarin-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
  • The concomitant use of certain drugs is prohibited; patients receiving List A drugs below are not eligible unless >= 7 days since last dose before starting sunitinib and no dosing during the trial; patients receiving List B drugs below are not eligible unless >= 12 days since last dose before starting sunitinib and no dosing during the trial
  • List A: inhibitor/substrates - prohibited 7 days before dosing and during study
  • Azole antifungals (ketoconazole, itraconazole, miconazole), verapamil, clarithromycin, human immunodeficiency virus (HIV) protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir), erythromycin, delavirdine, diltiazem
  • List B: inducer/substrates - prohibited 12 days before dosing and during study
  • Rifampin, phenytoin, rifabutin, St. John's wort, carbamazepine, efavirenz, phenobarbital, tipranavir
  • Patients with pre-existing hypothyroidism prior to enrollment are ineligible unless they are euthyroid on medication
  • Most women enrolled on this study will have had a prior hysterectomy for ovarian cancer; however, the following are exclusions for enrolment on the study:
  • Pregnant or lactating women; (N.B.: all women of childbearing potential must have a negative urine beta-human chorionic gonadotropin (b-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) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

This phase II trial studies the side effects and how well sunitinib malate works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they need to grow. It may also shrink tumors.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the efficacy (response rate) of sunitinib (sunitinib malate) given orally daily in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

II. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma.

III. To document cancer antigen 125 (CA125) response rate, early objective progression rate, and, if objective responses are observed, response duration.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

Being tested
sunitinib malate, laboratory biomarker analysis
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

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

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00388037
Study groupRoleWhat they receive
Treatment (sunitinib malate)ExperimentalPatients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sunitinib malate; Other: laboratory biomarker analysis

What is being measured

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

  1. Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    Partial response is defined as a 30% decrease in the sum of the longest diameters of the target lesion maintained for at least 4 weeks; complete response is defined as complete disappearance of disease and cancer related symptoms maintained for at least 4 weeks. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.

    Measured: Up to 3 years

Timeline

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

  1. First posted13 Oct 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2012
  4. Study completionJan 2012

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388037
Sponsor's protocol ID
NCI-2014-00647
Other IDs
NCI-2014-00647, IND.185, NCIC CTG IND.185, CAN-NCIC-IND185, I185, NCIC-185, NCIC-185
Status last verified
Apr 2014
First submitted
12 Oct 2006
Last updated
27 Jan 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate and laboratory biomarker analysis in people with Recurrent Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, 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 26 inclusion and 34 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 27 Jan 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 15 Jan 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 (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (time frame: Up to 3 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 NCT00388037.

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 27 Jan 2015.

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