A Phase II Study of Sunitinib (SU11248; NSC 736511) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- sunitinib malate
- Conditions
- Recurrent Fallopian Tube Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
- 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 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: sunitinib malate
Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Time Frame: Up to 3 years
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.