Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00979992|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2009
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Clear Cell Adenocarcinoma Recurrent Ovarian Carcinoma||Other: Laboratory Biomarker Analysis Drug: Sunitinib Malate||Phase 2|
I. To evaluate the anti-tumor activity of SU11248 (sunitinib malate), a highly potent, selective tyrosine kinases inhibitor, in patients with persistent or recurrent clear cell ovarian carcinoma.
II. To examine the nature and degree of toxicity in this cohort of patients treated with this regimen.
I. To characterize the distribution of progression-free survival and overall survival for patients treated with SU11248 (sunitinib malate).
I. To determine the pre-cycle 1, pre-cycle 4 and off-treatment levels of pro-angiogenic proteins (e.g., angiogenin, soluble vascular cell adhesion molecule [VCAM]-I, basic fibroblast growth factor [bFGF], platelet-derived growth factor [PDGF], placental growth factor [PlGF], vascular endothelial growth factor [VEGF], and hypoxia-inducible factor [HIF]1alpha).
II. To identify changes in serum and plasma angiogenesis markers at baseline (pre-cycle 1), during treatment (cycle 4), and at progression in association with primary and secondary clinical endpoints associated with clinical response or progression-free survival.
Patients receive sunitinib malate orally (PO) once daily (QD) for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of SU11248 (Sunitinib Malate) (NSC #736511) in the Treatment of Persistent or Recurrent Clear Cell Ovarian Carcinoma|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||May 2014|
U.S. FDA Resources
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Sunitinib Malate
- Objective Tumor Response Rate (Complete and Partial Response) [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years. ]Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
- The Percentage of Patients Who Survive Progression Free for at Least 6 Months [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months ]Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
- Overall Survival [ Time Frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. ]Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
- Progression-free Survival [ Time Frame: Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter for up to 5 years. ]Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1
- Number of Participants With Grade 3 or Higher Adverse Events [ Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up. ]Grade 3 or higher adverse events were graded by CTC AE v 4.
- Change in Pro-angiogenic Protein Levels [ Time Frame: Baseline to up to 5 years ]
- Changes in Serum and Plasma Angiogenesis Markers by Enzyme-linked Immunosorbent Assays [ Time Frame: Baseline to up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979992
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|Principal Investigator:||John Chan||NRG Oncology|