Phase 2
N=52
Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
Borderline Ovarian Serous Tumor · Low Grade Ovarian Serous Adenocarcinoma · Micropapillary Serous Carcinoma · Primary Peritoneal Carcinoma · Primary Peritoneal Low Grade Serous Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00551070 ↗Enrolled (actual)
52
Serious AEs
63.5%
Results posted
Jun 2015
Primary outcome: Primary: Tumor Response — 15.4 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Pharmacological Study (Other); Selumetinib (Drug); Selumetinib Sulfate (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response |
15.4 | — |
| PRIMARY Adverse Events (Grade 3 or Higher) During First Cycle of Treatment |
0; 0; 0; 2; 0; 0 | — |
| PRIMARY Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily. |
2419 | — |
| PRIMARY Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily. |
585 | — |
| SECONDARY Progression-free Survival |
11.3 | — |
| SECONDARY Number of Courses Received |
5 | — |
| SECONDARY Overall Survival |
32.4 | — |
Summary
This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Patients age greater than 18 with the following tumors are included in the study:
- Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by Gynecologic Oncology Group [GOG], International Federation of Gynecology and Obstetrics [FIGO] World Health Organization [WHO] or Silverberg)
- Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)
- Patients must have measurable disease:
- Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
- Patient must have documented low grade serous carcinoma (invasive micropapillary serous); confirmation must occur before patient is considered eligible for the trial
- Patients whose primary tumor was low-grade serous ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their primary or recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous)
- Patients whose primary tumor was serous borderline ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous)
- Creatinine CTCAE grade 0-1 ( = 1500/mcl)
- Platelets CTCAE grade 0-1 (>= 100,000/mcl)
- Neuropathy = 450 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
- Required use of a concomitant medication that can prolong the QT interval
- Patients should not receive any drugs known to affect or with the potential to affect selected CYP450 isoenzymes
- Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because the effects of AZD6244 on the developing human fetus at the recommended therapeutic dose are unknown; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with AZD6244
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD6244; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Data sourced from ClinicalTrials.gov (NCT00551070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.