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

NCT00388037 | Completed Phase 2 Results

• 6 other identifiers: NCI-2014-00647IND.185NCIC CTG IND.185CAN-NCIC-IND185I185NCIC-185
• Study Type: interventional
• Target: 31
• 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 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.

Conditions

Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Primary Peritoneal Cavity Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Primary Peritoneal Cavity Cancer

Outcome Measures

Primary Outcomes (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.

  Up to 3 years

Study Arms (1)

Treatment (sunitinib malate)

EXPERIMENTAL

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

Drug: sunitinib malate; Other: laboratory biomarker analysis

Interventions

sunitinib malate DRUG

Given PO

Also known as: SU11248, sunitinib, Sutent

Treatment (sunitinib malate)

laboratory biomarker analysis OTHER

Correlative studies

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 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
• 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

You may not qualify if:

• 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:
• 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

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

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

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. James Biagi
• Organization: Cancer Centre of Southeastern Ontario at Kingston

jim.biagi@krcc.on.ca

(613) 544-2630

Study Officials

• James Biagi

  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 12, 2006
• First Posted: October 13, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 27, 2015
• Results First Posted: January 15, 2015

Record last verified: 2014-04

Locations

CA (1)