Clinical trial · Interventional
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
NCT00768144CI-TRIAL-00034554completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib
- description
- Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
- interventionNames
- Drug: Sunitinib
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.
- description
- Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer * Recurrent or refractory disease * Measurable disease, defined by RECIST * 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease * Adverse events related to prior tumor-specific therapy must have resolved to less than or equal to grade 1 prior to study entry * Ability to swallow oral medications * 18 years of age or older * ECOG Performance status must be 0-2 * Normal organ and marrow function as outlined in the protocol Exclusion Criteria: * Receiving systemic therapy less than 14 days prior to starting sunitinib * Receiving any other investigational agent * Received prior sunitinib * Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on screening CT or MRI scans * Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3.0 grade 3 or worse hemorrhage within 4 weeks of starting study treatment * Ongoing cardiac dysrhythmias of NCI CTCAE version 3.0 grade \> 2 * Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication * Prolonged QTc interval on baseline EKG * Uncontrolled hypertension * Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin, theophylline, ketoconazole, or St. John's wort. * Psychiatric illness or social situations that wold limit compliance with study requirements * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration * Pregnant women * Clinical or radiographical evidence of a small bowel obstruction * Poor oral intake
References
Publications (0)
Data not yet available
No reference posted for this study.